Protocol Index	

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OP RESEARCH PRO00037588 IOV-GM1-201 SCREENING 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 2	Interval: --	Occurrences: --	Comments:	Informed consent - The most recently approved ICF must be signed before any study-related assessments are performed and may be obtained outside of the 28-day window prior to the tumor harvest. See Section 10.1.3 for more details.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Eligibility criteria - See the eligibility criteria in Sections 5.1 and 5.2.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographic information - Includes year of birth, age, sex, and race/ethnic origin.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Medical/surgical history and concurrent illnesses - Relevant and significant medical/surgical history and concurrent illnesses will be collected for all participants.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Cancer history - Pertinent available information related to cancer history (eg, diagnosis date, stage, grade) and treatment will be recorded. The participant must have documented diagnosis of the malignancy under study via a pathology report and the tumor mutational analysis report(s) must be available, if applicable. If the participant has a documented programmed death ligand 1 (PD-L1) expression status, as determined by the tumor proportion score (TPS) prior to any previous immune checkpoint inhibitor (ICI) treatment, this should be recorded
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical examination - The Screening physical examination includes assessments of the gastrointestinal (abdomen, liver) system; cardiovascular system; extremities; head, eyes, ears, and nose, and throat; respiratory system; skin; neurological system; and psychiatric (mental) status. Participants with a history of uveitis must have an eye examination performed by a trained eye specialist at Screening to rule out active uveitis that requires treatment. Height and weight will be recorded at Screening.
		  	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.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Include pulse rate, respiratory rate, systolic and diastolic blood pressure, and temperature.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	To be performed after participant has been supine for at least 3 minutes. If an electrocardiogram (ECG) has been performed within 60 days prior to Screening and was considered normal, it does not need to be repeated, unless clinically indicated. See Section 8.3.4 for more details
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Screening computed tomography (CT) scans of chest, abdomen, pelvis, and any relevant anatomic regions per disease history are required. Alternative imaging modalities as described in the Imaging Guidelines are permitted for participants who have an intolerability or known allergy to contrast media. 

Imaging performed within 28 days prior to signing of the ICF can be utilized for Screening. The imaging modality and anatomic regions assessed must be kept the same for all assessments while on study. See Section 8.2.1 for more details.
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	A screening CT or MRI of the brain is required for all participants. Imaging performed within 28 days prior to signing of the ICF can be utilized for Screening. The imaging modality and anatomic regions assessed must be kept the same for all assessments while on study. See Section 8.2.1 for more details.
		  	TRANSTHORACIC ECHOCARDIOGRAM STRESS W DOP W CONT IF NEEDED	Interval: --	Occurrences: --	Comments:	For participants GREATER than or EQUAL to  60 years of age OR who have a history of clinically relevant cardiac disease, a cardiac stress test (or equivalent local standard stress test) must be performed showing no irreversible wall movement abnormalities. If an ECHO/MUGA was performed within 6 months of the signed ICF, it does not need to be repeated. If it is local standard to perform cardiac magnetic resonance imaging (MRI), that is an acceptable alternative test. The ECHO/MUGA must confirm a left ventricular ejection fraction (LVEF) > 45%.
See Section 8.3.5 for more details
			Respiratory Care
  	INCENTIVE SPIROMETRY	Interval: --	Occurrences: --	Comments:	Spirometry will be performed for participants who have a history of cigarette smoking of GREATER than or EQUAL to 20 pack-years, ceased smoking within the past 2 years or continue to smoke, have a history of chronic obstructive pulmonary disease (COPD), or have any signs or symptoms of respiratory dysfunction. 
Evaluations completed within 28 days prior to signing the ICF will be accepted. 
If a participant is unable to perform reliable spirometry due to abnormal upper airway anatomy (ie, tracheostomy), a 6- minute walk test may be used to assess pulmonary function.
See Section 8.3.6 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
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	WOCBP = women of childbearing potential
Will be performed for all WOCBP at Screening, within 24 hours before the tumor harvest, and any other time clinically indicated.
If pregnancy is discovered at any point in time during the study, it must be reported immediately (see Appendix 3 [Section 10.3.5.2 and 10.3.5.3]
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --		  	SYPHILIS TREPONEMA SCREEN WITH RPR CONFIRMATION (REVERSE ALGORITHM)	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --