This study is investigating a new treatment approach for advanced melanoma that has not been treated before. It compares two groups: one receiving a combination of lifileucel and pembrolizumab, and another receiving pembrolizumab alone. Lifileucel involves using your own tumor cells to create a personalized treatment, while pembrolizumab is an immunotherapy that helps your immune system fight cancer. You may be eligible if you are between 18 and 70 years old, have unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) melanoma, and have a good performance status. The researchers want to see how many people respond to the treatments and how long they live without their cancer getting worse. This study aims to enroll 670 participants and its current status is unclear.

Study design

This is a Phase 3, multicenter, open-label, randomized study comparing two treatment groups for advanced melanoma, aiming to enroll 670 participants.

What's involved

If you are in the combination group, a tumor sample will be taken for lifileucel manufacturing, followed by pembrolizumab, a special conditioning regimen, lifileucel infusion, and IL-2. If you are in the pembrolizumab alone group, you will receive pembrolizumab every 6 weeks until your disease progresses.

Compensation

Not stated in the trial record.

Follow-up

The study will measure outcomes like Objective Response Rate and Progression Free Survival over a total duration of 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.