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

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

NCT Number	NCT05727904
Lead Sponsor	Iovance Biotherapeutics, Inc.
Conditions	Metastatic Melanoma, Unresectable Melanoma, Melanoma
Enrollment	670 participants
Start Date	2023-03-30
Primary Completion	2028-03-01 (estimated)
Study Completion	2030-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-26