Protocol Index	

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IP / OP RSH PRO00036343 / IMCGP100-203 / ARM B	

Types:      Research Oncology Treatment
Synonyms:  TEBENTAFUSP , MONOTHERAPY, IMCGP100, PRO00036343, ARM A, CGP100-203

IP Week 1	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Adverse events.
		  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI.

 More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. 

For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). 

NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Weight
			Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Once	Occurrences: --	Comments:	Full Physical Exam
 - A full physical examination is to be performed on Day -1 or pre-dose on Day 1.
			Imaging
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	HEMOGLOBIN & HEMATOCRIT	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: Once	Occurrences: --		  	T4, FREE	Interval: Once	Occurrences: --		  	T3, FREE	Interval: Once	Occurrences: --			Labs
  	URINALYSIS, DIPSTICK ONLY	Interval: Once	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: Once	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum for pharmacodynamics/ biomarkers. 
Serum samples for assessment of biomarkers/pharmacodynamics to be obtained from Weeks 1 to 3 pre-dose and 8 (±2 hr) and 16 to 24 hours (± 4 hr) post-EOI.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 975 mg	Dose: 1,000 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	-- Pembrolizumab is given every 6 weeks
-- When pembrolizumab and tebentafusp are administered on the same day, offset administration appropriately.
			Chemotherapy
  	pembrolizumab (KEYTRUDA) 400 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 400 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	400 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	84 mL	Yes	Yes				Chemotherapy
  	INV-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 20 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 20 mcg	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 90 Minutes	Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	20 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	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 83	Interval: Until discontinued	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 4	Interval: Until discontinued	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.
		  	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	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					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.				Day 2	Perform every 1 day x1		Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Adverse events.
		  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI.

 More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. 

For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). 

NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Weight
			Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Once	Occurrences: --	Comments:	Full Physical Exam
 - A full physical examination is to be performed on Day -1 or pre-dose on Day 1.
			Imaging
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	HEMOGLOBIN & HEMATOCRIT	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: Once	Occurrences: --		  	T4, FREE	Interval: Once	Occurrences: --		  	T3, FREE	Interval: Once	Occurrences: --			Labs
  	URINALYSIS, DIPSTICK ONLY	Interval: Once	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum for pharmacodynamics/ biomarkers. 
Serum samples for assessment of biomarkers/pharmacodynamics to be obtained from Weeks 1 to 3 pre-dose and 8 (±2 hr) and 16 to 24 hours (± 4 hr) post-EOI.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
					
IP Week 2	Repeat 1 time	Cycle length: 7 days	Day 8	Perform every 1 day x1		Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Adverse events.
		  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI.

 More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. 

For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). 

NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Labs
  	HEMOGLOBIN & HEMATOCRIT	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 975 mg	Dose: 1,000 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 30 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 30 mcg	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	30 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	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 83	Interval: Until discontinued	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 4	Interval: Until discontinued	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.
		  	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	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					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.				Day 9	Perform every 1 day x1		Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Adverse events.
		  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI.

 More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. 

For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). 

NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Labs
  	HEMOGLOBIN & HEMATOCRIT	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
					
IP Week 3	Repeat 1 time	Cycle length: 7 days	Day 15	Perform every 1 day x1		Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Adverse events.
		  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI.

 More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. 

For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). 

NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Imaging
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	HEMOGLOBIN & HEMATOCRIT	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum for pharmacodynamics/ biomarkers. 
Serum samples for assessment of biomarkers/pharmacodynamics to be obtained from Weeks 1 to 3 pre-dose and 8 (±2 hr) and 16 to 24 hours (± 4 hr) post-EOI.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 975 mg	Dose: 1,000 mg	Route: oral	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S				  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	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 83	Interval: Until discontinued	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 4	Interval: Until discontinued	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.
		  	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	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					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.				Day 16	Perform every 1 day x1		Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Adverse events.
		  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI.

 More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. 

For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). 

NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Imaging
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	HEMOGLOBIN & HEMATOCRIT	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum for pharmacodynamics/ biomarkers. 
Serum samples for assessment of biomarkers/pharmacodynamics to be obtained from Weeks 1 to 3 pre-dose and 8 (±2 hr) and 16 to 24 hours (± 4 hr) post-EOI.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
					
Week 4	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Labs
  	URINALYSIS, DIPSTICK ONLY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 5	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 6	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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 PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	-- Pembrolizumab is given every 6 weeks
-- When pembrolizumab and tebentafusp are administered on the same day, offset administration appropriately.
			Chemotherapy
  	pembrolizumab (KEYTRUDA) 400 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 400 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	400 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	84 mL	Yes	Yes				Chemotherapy
  	INV-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 90 Minutes	Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 7	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 8	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 9	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 10	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demography/medical history.
include a history of smoking, tuberculosis, HIV infection, and hepatitis B and C. Note: Testing for tuberculosis, HIV, and hepatitis B and C is not required unless mandated by the local health authority or based on strong clinical suspicion.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Full Physical Exam - A full physical examination is to be performed on Day -1 or pre-dose on Day 1.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brain imaging. : As Clinically indicated for Study Team to Order.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	CT/MRI scans/ RECIST 1.1. Tumor assessment is mandatory at Week 12 and then every 12 weeks thereafter until confirmation of progressive disease per RECIST 1.1, treatment discontinuation, or participant withdrawal/lost to follow-up
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 11	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demography/medical history.
include a history of smoking, tuberculosis, HIV infection, and hepatitis B and C. Note: Testing for tuberculosis, HIV, and hepatitis B and C is not required unless mandated by the local health authority or based on strong clinical suspicion.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Full Physical Exam - A full physical examination is to be performed on Day -1 or pre-dose on Day 1.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brief Physical Exam.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brain imaging. : As Clinically indicated for Study Team to Order.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	CT/MRI scans/ RECIST 1.1. Tumor assessment is mandatory at Week 12 and then every 12 weeks thereafter until confirmation of progressive disease per RECIST 1.1, treatment discontinuation, or participant withdrawal/lost to follow-up
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S			Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
Week 12	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	o Administer the first 3 tebentafusp-tebn infusions in an appropriate health care setting with immediate access to medications and resuscitative equipment to manage cytokine release syndrome;  
o If the patient did not experience GREATER than or EQUAL to grade 2 hypotension (requiring medical intervention) during or after the third infusion, may administer subsequent doses in an ambulatory care setting. 
o HLA-A*02:01 status should be determined prior to initiation of therapy.  HLA-A*02:01 status: Please Push F2:22332.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Treatment conditions.
Hold and notify physician if
o LFTs GREATER than 5x ULN; (>3.0 - 5.0 x ULN if baseline was normal; >3.0 - 5.0 x baseline if baseline was abnormal) 
o Bilirubin GREATER than 3x ULN.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing communication
o For the first three infusions, monitor body temperature, heart rate, respiratory rate, blood pressure - Vitals collected at MINIMUM every 4 hours.  
o For the first three infusions, patients should be monitored at least 16 hours. 
o If the patient does not experience GREATER than or EQUAL to Grade 2 hypotension (requiring medical intervention) during or after the first three infusions, monitor patients for a MINIMUM of 30 minutes following each of these infusions in an ambulatory setting.
Nursing communication
o If the patient experienced grade GREATER than or EQUAL to 3 hypotension (requiring medical intervention) at C1D1, C1D8, or C1D15, must monitor vital signs every hour for a MINIMUM of 8 hours after dosing for any doses administered as an ambulatory through C3D1.
Nursing communication
o Patients with break or delay in treatment for GREATER THAN 2 weeks AND with history of a grade GREATER than or EQUAL to 3 event of hypotension (requiring medical intervention) with Tebentafusp-tebn dosing during the first weeks of treatment, will require monitoring in an appropriate healthcare setting with vital signs performed at a minimum of every 4 hours and monitoring for at least 16 hours after dosing for all subsequent doses.
Nursing communication
o HOLD tebentafusp-tebn and alert oncologist if drop in oxygen saturation LESS than 88% or systolic blood pressure LESS than 90 mmHg.
			Line Flush
  	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 PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	-- Pembrolizumab is given every 6 weeks
-- When pembrolizumab and tebentafusp are administered on the same day, offset administration appropriately.
			Chemotherapy
  	pembrolizumab (KEYTRUDA) 400 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 400 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	400 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	84 mL	Yes	Yes				Chemotherapy
  	INV-Tebentafusp (IMCgp100-203/Pro00036343/Bernicker) 68 mcg in albumin human 5 % 0.5 mL, sodium chloride 0.9% 100 mL IVPB	Dose: 68 mcg	Route: intravenous	once over 15 Minutes for 1 dose			Offset: 90 Minutes	Instructions:	Infuse IV over 15-20 minutes using a 0.2 micron inline filter.  Solution expires 4 hours after puncture of vial, including infusion time. Infuse entire bag (110mL). Flush with NS. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TEBENTAFUSP (IMCGP100-203/PRO00036343/BERNICKER) 0.1 MG INTRAVENOUS SOLN	Medications	68 mcg	Main Ingredient	Yes	ALBUMIN, HUMAN 5 % WRAPPER	Base	0.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	100 mL	Yes	Yes				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.
		  	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
  	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					
E/D(Early Discontinuation)	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brain imaging. : As Clinically indicated for Study Team to Order.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	CT/MRI scans/ RECIST 1.1. Tumor assessment is mandatory at Week 12 and then every 12 weeks thereafter until confirmation of progressive disease per RECIST 1.1, treatment discontinuation, or participant withdrawal/lost to follow-up
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, DIPSTICK ONLY	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp PK sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tebentafusp ADA sample collection to occur in the Phase 2 portion only. Week 1 and Week 3: pre-dose (within 2 hr), EOI (within 15 min), and 4 (±1 hr), 8 (±1 hr), and 16-24 (± 4 hr) hours post-dose. All other PK sample collection days: pre-dose (within 2 hr) and EOI (within 15 min) . For Phase 2 and Phase 3, an unscheduled PK sample should be collected immediately (within 15 min) after any ECG that is performed due to an unexpected cardiac adverse event.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
					
Disease Progression Follow-Up	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Brain imaging. : As Clinically indicated for Study Team to Order.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	CT/MRI scans/ RECIST 1.1. Tumor assessment is mandatory at Week 12 and then every 12 weeks thereafter until confirmation of progressive disease per RECIST 1.1, treatment discontinuation, or participant withdrawal/lost to follow-up
					
FU- 30, 60 and 90 days	Repeat 3 times	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival contact.
			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, DIPSTICK ONLY	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for DNA
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood (PAXgene) for mRNA.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood for PBMCs.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Plasma for ctDNA. Plasma samples for ctDNA are to be collected pre-dose (within 2 hr) on dosing days and Q6W from Week 9. The sample window is ± 2 weeks from all designated time points after Week 9. Participants should be asked to come to the clinic for the Week 9 ctDNA sample collection even in the event of early discontinuation from the study
					
Survival Follow-up ( Q3M )	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
Overall survival[RAC1]  should be recorded at all E/D, including those taking place prior to Week 9 of the study.
Follow-up (30, 60, and 90 days after last dose).
Survival Follow-up Q3M
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	For the first 3 doses of Tebentafusp, vital signs are to be assessed pre-dose (within 2 hr) and then at least every 4 hours (± 30 min) through at least 16 hours post-EOI. More frequent assessments should be done if clinically indicated during Weeks 1 to 3 and for any other dose when extended monitoring is clinically indicated. For subsequent doses, vital signs are to be assessed pre-dose (within 2 hr) (±and at least once prior to discharge. Participants should be monitored for a minimum of 1-hour post-EOI (+ 15 min). NOTE: For participants who have received outpatient treatment with Tebentafusp for at least 3 months without interruption, monitoring may be decreased to minimum of 30 minutes post-EOI (+ 15 min).
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent anticancer therapy.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival contact.