Study # IOV-MEL-301
A Phase III, Multicenter, Randomized, Open-Label, Parallel group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor-Infiltrating Lymphocytes [TIL]) Regimen in Combination with Pembrolizumab compared with Pembrolizumab Monotherapy in Participants with Untreated, Unresectable or Metastatic Melanoma
A Phase III, Multicenter, Randomized, Open-Label, Parallel group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor-Infiltrating Lymphocytes [TIL]) Regimen in Combination with Pembrolizumab compared with Pembrolizumab Monotherapy in Participants with Untreated, Unresectable or Metastatic Melanoma
Meta
Study Status:
Enrolling
Treatment Agent:
Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period
Description
Short Title: IOV-MEL-301
We are the first site to open this study in the world! This study is a Phase III study of lifileucel plus pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. The combination has the potential for enhanced antitumor activity through the combination of programmed cell death protein-1 (PD-1) blockade allowing for optimal engraftment, increased cytotoxicity, and intratumoral expansion of the infused lifileucel product. Continued pembrolizumab therapy after lifileucel infusion is expected to perpetuate the antitumor effect.
Resources and Links
National Clinical Trial Identified Number: NCT05727904