Phase 3 Study Comparing Lifileucel with Pembrolizumab Versus Pembrolizumab Alone in Adults with Untreated Advanced Unresectable or Metastatic Melanoma

What this Trial Is About

Researchers are evaluating a treatment for participants with untreated, unresectable, or metastatic melanoma at advanced stages Stage IIIC, IIID, or IV. This Phase 3, multicenter, open-label study compares a combination of lifileucel and pembrolizumab against pembrolizumab alone, focusing on efficacy and safety. The study includes participants who have not received prior therapy for metastatic disease, though some prior adjuvant or neoadjuvant therapies completed at least 6 months before progression are allowed. Participants in the study are assigned to one of two groups one receives pembrolizumab with lifileucel, and the other receives pembrolizumab alone. Lifileucel treatment involves surgically removing a tumor sample for manufacturing, followed by lymphodepletion, lifileucel infusion, and IL-2 therapy. Pembrolizumab is administered every 6 weeks until disease progression. Participants initially receiving pembrolizumab alone who experience confirmed disease progression may opt to receive lifileucel monotherapy in an optional crossover period. During the study, participants undergo tumor resection and regular treatment cycles. Researchers will assess outcomes such as objective response rate, progression-free survival, overall survival, complete response rate, duration of response, event-free survival, and adverse events over several years. Safety and efficacy are monitored throughout, with follow-up lasting up to 7 years to evaluate long-term outcomes and disease progression.

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.