Recruiting

Testing a new combination treatment for advanced melanoma

Plain-English translation of NCT06112314 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 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 combining a new medication called with a standard melanoma drug () helps people with advanced melanoma live longer and healthier than standard treatment alone. Researchers believe this medication works by training the immune system to recognize and fight melanoma cells more effectively. About 680 people will join this trial to find out which approach works best.

Advanced melanoma can be very difficult to treat, and while some patients benefit from current treatments, many do not respond well or their cancer comes back. This trial is looking to see if the new treatment can help more patients with advanced melanoma by combining two different ways of boosting the immune system to fight the cancer.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced melanoma (Stage IV or unresectable Stage III) that has never been treated with prior systemic cancer therapy
you have a specific genetic marker called HLA-A*02:01
your tumor tissue is available for testing to confirm it is adequate
you have measurable disease that can be tracked on imaging scans
you are in good overall health (Eastern Cooperative Oncology Group performance status of 0 or 1)
you are willing to use effective birth control if you are of childbearing age and sexually active

You likely don't qualify if…

you have another active cancer besides melanoma
you have untreated melanoma that has spread to your brain or spinal cord
you have had a severe allergic reaction to similar medications in the past
you have significant lung, heart, or active autoimmune disease that is not well controlled
you previously received anti-PD-1 or anti-LAG-3 treatments and had a serious side effect

What participation looks like

You will be randomly assigned to receive either the new medication plus standard treatment, or standard treatment alone. If you receive the new medication, you will get infusions once a week for the first 13 weeks, then every 2 weeks until week 51, and then every 4 weeks after that. The standard treatment is given once every 4 weeks. You will visit the clinic regularly for infusions, blood tests, and imaging scans to monitor how well the treatment is working and to watch for any side effects.

AI-generated summary from trial data · Jun 9, 2026 · Not medical advice

Trial locations(211 sites)

United States

University of Arizona, Tucson, Arizona

University of California - San Diego, La Jolla, California

The Angeles Clinic and Research Institute- West Los Angeles, Los Angeles, California

ESC Norris Comprehensive Cancer Center, Los Angeles, California

UCLA Hematology/Oncology, Los Angeles, California