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OP RSH PRO00041722  NIRAVATH RLY-2608-102 ARM 1	

Types:      Research Oncology Treatment
Synonyms:  RLY-2608-102

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Randomization
Randomization and C1D1 should ideally occur on the same day.
			Nursing Orders
  	ONC NURSING COMMUNICATION 116	Interval: --	Occurrences: --	Comments:	Medical history - Only changes from the previous visit need to be collected on C1D1.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 25	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 26	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 27	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	HIV, HBV, and HCV tests

HIV, HBV, and HCV tests performed prior to signing of the ICF are acceptable for use at screening as long as the tests were performed within 28 days prior to
randomization. Testing is required only for participants with known or suspected infection. Participants with known HIV who are enrolled in the study should undergo monitoring of HIV viral load (HIV RNA PCR) and CD4+ T-cell count on C2D1, C3D1, D1 of every odd-numbered cycle thereafter, and at EOT. Refer to Table 11 for details of HIV, HBV, and HCV testing requirements
			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 28	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23
			Nursing Orders
  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	RLY-2608.RLY-2608 400mg should be taken orally BID with food (within 30 minutes after starting a meal) continuously during each 28-day cycle. Update the dose for dose reductions.
			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment (EOT) - Within 14 days post last dose	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 67	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate 12-lead ECG. Participants will undergo ECG monitoring by 12-lead ECG evaluations with triplicate readouts. Twelve-lead ECGs are to be conducted/extracted after >=5 minutes of recumbency or semi recumbency. All ECGs are to be collected prior to dosing
			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Coagulation and urinalysis are only required at screening and EOT but may be completed more frequently if clinically indicated. For urinalysis, collection of urine urobilinogen and urine bilirubin is optional PT, INR, and aPTT pH, specific gravity, blood, glucose, ketones, leukocyte esterase, nitrite, protein,urobilinogen, and bilirubin
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Coagulation and urinalysis are only required at screening and EOT but may be completed more frequently if clinically indicated. For urinalysis, collection of urine urobilinogen and urine bilirubin is optional PT, INR, and aPTT pH, specific gravity, blood, glucose, ketones, leukocyte esterase, nitrite, protein,urobilinogen, and bilirubin
			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --	Comments:	HbA1c will be assessed at screening, predose on C3D1, and D1 of every 4 cycles thereafter (i.e. C7, C11, C15...), and at EOT.
			Labs
◉	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
		◯	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	A serum pregnancy test will be performed for females of childbearing potential within 7 days prior to randomization. Either a serum or urine pregnancy test will be performed on D1 of each subsequent cycle.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Coagulation and urinalysis are only required at screening and EOT but may be completed more frequently if clinically indicated. For urinalysis, collection of urine urobilinogen and urine bilirubin is optional.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Imaging
◉	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Chemotherapy
  	INV-FULVESTRANT (RLY2068-102/PRO00041722/NIRAVATH) INTRAMUSCULAR INJECTION 500 mg	Dose: 500 mg	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Safety follow up (SFU) 30 days post last dose Progression free	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar[AR1]  for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  RLY-2608-102_Niravath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Treatment: Refer to Section 6.3 Protocol Access hyperlink:  RLY-2608-102_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	AE/SAE monitoring
AEs and SAEs are required to be captured through 30 days after the last dose of study treatment or until the start of new antineoplastic treatment, whichever occurs first. All SAEs should be reported in accordance with Section 9.8.
			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Survival Status
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical examination
complete physical examination will be performed at the screening visit. Subsequent physical examinations will be disease- and AE-focused
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Imaging
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG Performance Status.Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count with differential (including ANC), RBC count, hemoglobin,hematocrit, and platelet count
Participant is required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required. Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants are required to meet eligibility within 3 days prior to randomization. If screening visit tests are performed within 3 days prior to randomization, assessments do not need to be repeated on C1D1. For subsequent visits, timely review of all safety data is required.Participants will need to fast for at least 8 hours for fasting glucose assessment.
					
Progression free survival FU (PFS) every 8 weeks	Repeat 1 time	Cycle length: 56 days	Day 1	Perform every 8 days x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	RECIST v1.1 tumor assessments
Tumor imaging and assessment per RECIST v1.1 via CT with IV contrast of the chest, abdomen, and pelvis (or MRI where IV contrast CT is contraindicated) is required
at screening, on D1 of odd-numbered cycle starting with C3, and at EOT. Imaging may be completed more frequently if clinically indicated. For each participant, the same method for tumor imaging used at baseline will be used throughout the study. If an off-schedule imaging assessment is performed, subsequent imaging assessments should be performed in accordance with the original imaging schedule. In case of clinical evidence of metastatic disease in the CNS, imaging such as brain MRI should be conducted at baseline. Subsequent imaging by the same modality in participants with CNS metastases should be performed at the time of RECIST response assessments. Refer to Sections 8.9.1 and 8.9.2 for more details.
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Subsequent cancer therapy following discontinuation of study treatment. Details of next-line treatment will be documented by site personnel at the 30-day Safety Follow-up visit, at the PFS follow-up visit, and during the OS follow-up period. Date of progression on the first subsequent therapy as determined by the Investigator will be documented by site personnel during the OS follow-up period (every 12 weeks thereafter until second disease progression per Investigator assessment).
					
Overall survival FU (OS) every 12 weeks	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 84 days x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Survival Status
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Subsequent cancer therapy following discontinuation of study treatment. Details of next-line treatment will be documented by site personnel at the 30-day Safety Follow-up visit, at the PFS follow-up visit, and during the OS follow-up period. Date of progression on the first subsequent therapy as determined by the Investigator will be documented by site personnel during the OS follow-up period (every 12 weeks thereafter until second disease progression per Investigator assessment).