RecruitingPhase 2NCT07288203

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma


Sponsor

Iovance Biotherapeutics, Inc.

Enrollment

100 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes \[TIL\]) in participants with previously treated advanced melanoma


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying lifileucel — a treatment made from your own tumor-fighting immune cells (called tumor-infiltrating lymphocytes, or TILs) that are grown in a lab and infused back — for people with advanced melanoma that has not responded to immunotherapy. **You may be eligible if...** - You are an adult with advanced (Stage IIIC, IIID, or IV) unresectable or metastatic melanoma - Your melanoma has continued to grow or spread during or after treatment with an anti-PD-(L)1 drug - Your performance level is good (ECOG 0 or 1) with life expectancy over 6 months - You have at least one tumor that can be surgically removed to make the TIL therapy - If your tumor has a BRAF V600 mutation, you may have had one additional prior BRAF/MEK inhibitor treatment **You may NOT be eligible if...** - Your melanoma has not been treated with immunotherapy yet - You cannot have surgery to collect tumor tissue - Your performance level or organ function is too poor for this intensive treatment - You have active brain metastases that are untreated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALLifileucel

A tumor sample is resected from each patient for lifileucel manufacturing. Patients will first receive the preparative non-myeloablative lymphodepletion (NMA-LD) regimen. They will then receive the lifileucel infusion, followed by an abbreviated course of aldesleukin.


Locations(5)

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, Canada

Centre Hospitalier de l'Universite de Montreal

Montral, Quebec, Canada, Canada

Royal Marsden Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07288203


Related Trials