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OP RSH PRO00041722 NIRAVATH RLY-2608-102 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00041722 RLY-2608-102 NIRAVATH, NIRAVATH

Screening	Repeat 1 time	Cycle length: 28 days	-28 Days	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:	Informed Consent - The ICF should be signed prior to starting screening assessments and within 28 days before randomization.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion
criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Cancer history and prior
treatment
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Medical history - A complete medical history will be obtained at the screening visit. Only changes from the previous visit need to be collected on C1D1.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	A complete physical examination will be performed at the screening visit.
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
			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
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE HEIGHT AND LENGTH	Interval: --	Occurrences: --	Comments:	Height will be measured at screening only.
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			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 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	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	ECHO/MUGA (LVEF).
ECHO (or MUGA) will be performed during screening only if a participant has risk factors for reduced cardiac function (e.g., Stable class 1 or 2 CHF according to the
NYHA classification, prior treatment with anthracyclines, left chest irradiation). The modality of the cardiac function assessments must be consistent within participant,i.e., if ECHO is used for the screening assessment, and a follow-up assessment if clinically indicated, then ECHO should also be used for subsequent assessments.
Participants should also be examined using the same machine and operator whenever possible
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	ECHO/MUGA (LVEF).ECHO (or MUGA) will be performed during screening only if a participant has risk factors for reduced cardiac function (e.g., Stable class 1 or 2 CHF according to the
NYHA classification, prior treatment with anthracyclines, left chest irradiation). The modality of the cardiac function assessments must be consistent within participant,i.e., if ECHO is used for the screening assessment, and a follow-up assessment if clinically indicated, then ECHO should also be used for subsequent assessments.
Participants should also be examined using the same machine and operator whenever possible
			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
◉	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
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Bone scan will be performed at baseline for all participants during screening. Scans performed as part of routine clinical management are acceptable for use as screening scans if they are of diagnostic quality and within 28 days prior to randomization. Bone scans should be repeated as clinically indicated during the study. Bone scan is required at time of CR to confirm CR.
		◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	Bone scan will be performed at baseline for all participants during screening. Scans performed as part of routine clinical management are acceptable for use as screening scans if they are of diagnostic quality and within 28 days prior to randomization. Bone scans should be repeated as clinically indicated during the study. Bone scan is required at time of CR to confirm CR.
			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 will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
		☑	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Participants will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Participants will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Inorganic phosphorus
Participants will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	Participants will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
		☑	AMYLASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
		☑	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	Participants will need to fast for at least 8 hours for fasting glucose assessment.
Sodium, potassium, BUN or urea, bicarbonate or total CO2 (venous), creatinine, calcium, chloride, magnesium, phosphate, albumin, total protein, AST, ALT, ALP,total and direct bilirubin, glucose, amylase, and lipase
			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
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	To be tested at screening only for all women to confirm menopausal status. Testing is not required in women who have undergone bilateral oophorectomy.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	To be tested at screening only for all women to confirm menopausal status. Testing is not required in women who have undergone bilateral oophorectomy.
			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
◉	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: --	Comments:	To determine eligibility, a fresh blood sample is required from all participants during screening for submission to central laboratory to determine the PIK3CA mutational status prior to randomization. Other tumor alterations relevant to ABC will also be assessed using the same sample. In case a participant is rescreened, another sample is not required if rescreening occurs within 3 months of the previous sample collection. The sample should be obtained as early as possible during screening to allow
sufficient time for shipping, processing, analysis, and reporting at the central laboratory. Results will be reported back to study sites to confirm eligibility and for stratification by PIK3CA mutation type at randomization.
			Procedures
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Pretreatment tumor tissue samples are mandatory. A recent archival tumor tissue sample can be submitted and if that is not available, then samples are to be collected fresh (preferred) within the study screening period