Recruiting

Testing a combination of two drugs for rare melanoma in the body

Plain-English translation of NCT05384496 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether combining nivolumab (an immunotherapy drug) with (a targeted therapy drug) can help treat mucosal melanoma—a rare and serious form of skin cancer that starts inside the body in areas like the mouth, throat, digestive tract, or urinary organs. If the cancer comes back or spreads despite this treatment, doctors may add radiation therapy or a third medication called ipilimumab to strengthen the immune response. The goal is to give people with this hard-to-treat cancer better options.

Mucosal melanoma is extremely rare but very aggressive, and current standard treatments do not work well for all patients. Researchers believe that combining these medications in different ways might help more patients control their cancer and live longer.

Do you qualify?

You likely qualify if…

you have been diagnosed with mucosal melanoma (a rare cancer starting in the moist linings of your head, throat, stomach, or urinary tract) that cannot be removed by surgery or has spread
you have not received any prior chemotherapy or immunotherapy drugs for your cancer
you have measurable disease that can be seen on scans
you are at least 18 years old and in reasonably good overall health (ECOG performance status 0–2)
your blood counts and liver and kidney function tests are within acceptable ranges

You likely don't qualify if…

you have an active autoimmune disease that requires ongoing systemic treatment
you have received prior systemic chemotherapy or immunotherapy for melanoma
your blood counts are too low or your liver or kidney function is severely impaired
you are unable or unwilling to use two forms of contraception if you are of childbearing age and sexually active

What participation looks like

You would receive the two medications as your primary treatment: one as an intravenous infusion every 4 weeks and the other as pills taken by mouth twice daily. Treatment would continue for up to 2 years unless your cancer gets worse or you cannot tolerate the side effects. If your cancer progresses but you tolerate the medications well, doctors may recommend adding radiation therapy to specific areas or a third immunotherapy drug. You would have regular clinic visits for blood tests, scans, and check-ins with your medical team throughout the study.

AI-generated summary from trial data · Jun 15, 2026 · Not medical advice

Trial locations(2 sites)

United States

Memorial Sloan Kettering Westchester, Harrison, New York

Memorial Sloan Kettering Cancer Center, New York, New York