Protocol Index	

If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

OP RESEARCH PRO00037588 IOV-GM1-201 TUMOR HARVEST 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 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 20	Interval: --	Occurrences: --	Comments:	Tumor harvest for IOV-4001 generation - Resect at least 1 lesion (or aggregate of lesions). See Section 6.1.1 for more details.
		  	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.
			Labs
  	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
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	FFPE = formalin-fixed, paraffin-embedded
To be collected during tumor harvest after the tumor tissue for IOV-4001 generation has been procured. See Section 8.8.1 for more details.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	See the Laboratory Manual and for more details
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	KO = knockout
See the Laboratory Manual for more details.