This international, multicenter, randomized, open-label, parallel-group Phase 3 study assesses the efficacy and safety of the lifileucel regimen (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) in combination with pembrolizumab compared with pembrolizumab monotherapy. The primary objective of the trial is to evaluate the efficacy of the combination regimen. Eligible participants include adult patients with untreated, unresectable, or metastatic melanoma. Participants are randomized to receive either the lifileucel and pembrolizumab combination or pembrolizumab monotherapy. Key secondary endpoints include additional clinical measures of efficacy and safety.
This international, multicenter, randomized Phase 3 clinical trial evaluates a new combination treatment for patients with advanced melanoma (black skin cancer) that cannot be surgically removed or has already spread to other parts of the body. The study investigates the efficacy and safety of a therapy using the patient's own immune cells, known as tumor-infiltrating lymphocytes (lifileucel), combined with an established immunotherapy drug (pembrolizumab). This combination is directly compared against pembrolizumab therapy alone. Adult patients who have not received prior treatment for their advanced cancer are eligible to participate. The primary goal of the study is to determine whether this combined cellular and immunotherapy approach is more effective at halting disease progression than the standard single-drug therapy.
