Recruiting

Testing two medications combined with standard immunotherapy for advanced melanoma

Plain-English translation of NCT05968690 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This study is testing whether adding and to standard immunotherapy (ipilimumab and nivolumab) can help treat advanced melanoma more effectively. Researchers want to learn if these two additional medications are safe when combined with the immunotherapy drugs already known to help with this cancer. This is an early-stage trial (Phase 1) designed primarily to make sure the combination is tolerable.

Advanced melanoma is a serious form of skin cancer, and while immunotherapy drugs like ipilimumab and nivolumab help some patients, researchers believe adding other medications might enhance the treatment's effectiveness or help more people respond to it.

Do you qualify?

You likely qualify if…

you are 18 years or older and able to understand and sign an informed consent form
you have been diagnosed with advanced (stage III or IV) melanoma that cannot be surgically removed
you are in good enough health to tolerate the study treatment, with a performance status of 0–1 (able to carry out most normal activities)
your blood counts and organ function are within acceptable ranges (determined by blood tests)
you have at least one tumor that can be measured by CT or MRI imaging
you are willing to have a tumor biopsy before and during the study to help researchers understand how the treatment works

You likely don't qualify if…

you have untreated melanoma that has spread to your brain (unless you meet specific criteria discussed with the study doctor)
you are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for 6 months after
you have severe organ damage or very low blood cell counts
you are taking a small-molecule targeted therapy drug (you must wait at least 2 weeks after stopping before joining)

What participation looks like

You would take two oral medications daily ( and ) along with the standard immunotherapy drugs. The immunotherapy is given intravenously every 3 weeks for up to 4 cycles, then continues as a single drug every 4 weeks. You would have blood tests, imaging scans, and tumor biopsies to monitor how you're responding and track any side effects. The study takes place at a single institution, and you'll be monitored closely to ensure the medication combination is safe.

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

Trial locations(1 site)

United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey