Recruiting

Testing a new cell therapy combined with immunotherapy for advanced melanoma

Plain-English translation of NCT05727904 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated July 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing whether lifileucel, a personalized cell therapy made from your own immune cells, works better when combined with the immunotherapy drug pembrolizumab compared to pembrolizumab alone. Lifileucel is created by removing immune cells from your tumor, growing many more of them in a laboratory, and then putting them back into your body to fight the cancer. The trial will compare this combination approach with the standard immunotherapy treatment to see which helps people with advanced melanoma live longer and control their disease better.

Immunotherapy drugs like pembrolizumab have helped many melanoma patients, but some people's cancer still progresses or stops responding. This medication may work by giving the immune system a stronger, more personalized boost to fight melanoma cells, and researchers want to see if combining it with immunotherapy produces better results than immunotherapy alone.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced melanoma (Stage IIIC, IIID, or IV) that cannot be surgically removed or has spread to other parts of your body
you have not received any prior treatment for metastatic (advanced) melanoma
you have at least one tumor that doctors can surgically remove to collect immune cells for the therapy
you are in good enough health to tolerate the treatment, with a life expectancy of more than 6 months
you have adequate organ function as confirmed by blood tests and other medical evaluations
you are willing to use reliable birth control if you could become pregnant or father a child

You likely don't qualify if…

you have received prior treatment specifically for metastatic melanoma
you have untreated melanoma that has spread to your brain and is causing symptoms
you have melanoma that originated in your eye (uveal or ocular melanoma)
you have a weakened immune system or a history of immune deficiency conditions
you have had another cancer diagnosis within the past 3 years (with limited exceptions)

What participation looks like

If you are assigned to the treatment group, doctors will perform surgery to remove a tumor or part of a tumor so they can collect your immune cells and grow them into lifileucel in a laboratory. Once the cells are ready, you will receive chemotherapy to prepare your body, followed by an infusion of the lifileucel cells back into your bloodstream. You will then receive pembrolizumab infusions on a regular schedule. Throughout the study, you will have frequent clinic visits for blood work, imaging scans, and physical exams to monitor how well the treatment is working and watch for any side effects. If you are assigned to the comparison group, you will receive pembrolizumab alone, and you may have the option to switch to the combination treatment later if your cancer progresses.

AI-generated summary from trial data · Jul 4, 2026 · Not medical advice

Trial locations(81 sites)

United States

University of Alabama at Birmingham: The Kirklin Clinic, Birmingham, Alabama

City of Hope, Duarte, California

USC Norris Comprehensive Cancer Center, Los Angeles, California

California Pacific Medical Center, San Francisco, California

University of Colorado Cancer Center, Aurora, Colorado