A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma

Condition studied

Previously treated advanced melanoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

ORR is defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 (timeframe: from the date of the lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause, whichever occurs first [up to a maximum of 5 calendar years after the lifileucel infusion]).

Endpoint detail

1. ORR is defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 (timeframe: from the date of the lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause, whichever occurs first [up to a maximum of 5 calendar years after the lifileucel infusion])., 2. CR rate is defined as the proportion of participants who have a confirmed CR per RECIST v1.1 from the date of the lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause, whichever occurs first (up to a maximum of 5 calendar years after the lifileucel infusion)., 3. DOR is measured from the first time that criteria are met for CR or PR per RECIST v1.1 until disease progression or death due to any cause (up to a maximum of 5 calendar years after the lifileucel infusion)., 4. DCR is measured by the percentage of participants with a best overall confirmed response of CR or PR at any time or SD ≥ 4 weeks per RECIST v1.1 from the date of the lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause, whichever occurs first (up to a maximum of 5 calendar years after the lifileucel infusion)., 5. PFS is defined as the time from the date of the lifileucel infusion until disease progression per RECIST v1.1 or death due to any cause (up to a maximum of 5 calendar years after the lifileucel infusion)., 6. OS is the time from the date of the lifileucel infusion to death due to any cause (up to a maximum of 5 calendar years after the lifileucel infusion)., 7. The safety of lifileucel will be characterized by the severity, seriousness, relationship to study intervention, and characteristics of REAE and TEAEs, including SAEs, study intervention-related AEs, and AEs leading to early discontinuation of study intervention or death (event monitoring periods will be defined based on the type of event).