Protocol Index	

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OP RESEARCH PRO00037588 IOV-GM1-201 BASELINE GANGULY	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   IOV-GM1-201 Protocol v2 Amendment v1_18Mar2022.pdf
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Autologous TIL regimen Treatment :  Refer to Section 6.1.4 Protocol Access Hyperlink:   IOV-GM1-201 Protocol v2 Amendment v1_18Mar2022.pdf
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Unless specified otherwise , all labs, imaging, and other orders should be completed 28 Days BEFORE IOV-4001 administration.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical examination - Subsequent physical examinations will be symptom-directed.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Treatment of active infection prior to NMA-LD - Participants with evidence of any uncontrolled or active systemic infection requiring ongoing treatment cannot proceed to NMA-LD. Prophylactic anti-infectious therapy is acceptable. See Section 6.8.2.1 for more details
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Record use of prior or concomitant medications - All medications, therapies, or interventions, including those that are part of the tumor harvest procedure, received by the participant starting 28 days prior to Screening must be recorded. See Section 6.8 for more details on both prohibited and required treatments
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Pre-treatment medical event collection - Medical occurrences that begin after obtaining informed consent but before the start of NMA-LD and are related to performance of screening or baseline assessments (and are unrelated to the tumor harvest) will be recorded as pretreatment medical events, not as AEs.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Tumor harvest-related AE collection - All AEs and SAEs related to the tumor harvest with an onset up to 30 days following the procedure will be collected
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Record details of any hospitalization(s) - For each hospitalization, the date of admission, date of discharge, the hospital unit, and reason for hospitalization will be recorded.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Confirmation of health status - The investigator must confirm the participant's health status, based on baseline assessments to ensure that the participant is stable to proceed to administration of the TIL regimen (NMALD, IOV-4001, and IL-2). This will be documented on the Health Status Re-confirmation Form. The Authorization to Receive Lymphodepletion Form also will be completed by the appropriate site staff. Both forms will be sent to the sponsor or  designee for review
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include pulse rate, respiratory rate, systolic and diastolic blood pressure, and temperature.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Baseline imaging (CT scans of chest, abdomen, pelvis, and any relevant anatomic regions per disease history) must be obtained post-tumor harvest for IOV-4001 generation and before any study therapy is initiated, including NMA-LD. See Section 8.2.1 for more details
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Repeat baseline brain imaging is required for participants with a history of brain metastases or if clinically indicated.
See Section 8.2.1 for more details
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Calculate estimated creatinine clearance using the Cockcroft-Gault calculation
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The human leukocyte antigen (HLA) typing sample will be analyzed by the central laboratory