This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment studyto assess the efficacy and safety of lifileucel in combination with pembrolizumabcompared with pembrolizumab alone in participants with untreated, unresectable ormetastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm whosubsequently have a blinded independent central review- verified confirmed progressivedisease (PD) will be offered lifileucel monotherapy in an optional crossover period.
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment studyto assess the efficacy and safety of lifileucel in combination with pembrolizumabcompared with pembrolizumab alone in participants with untreated, unresectable ormetastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm whosubsequently have a blinded independent central review- verified confirmed progressivedisease (PD) will be offered lifileucel monotherapy in an optional crossover period.