Two drug combinations for melanoma that has spread to the brain

Plain-English translation of NCT04511013 on ClinicalTrials.gov ↗ · Source last updated September 2025 · 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 a three-drug combination called , , and works better than a two-drug combination of and for treating melanoma that has metastasized (spread) to the brain. You would be randomly assigned to receive one of these two treatment combinations. The trial aims to find out which approach helps people live longer without their cancer progressing.

Melanoma that spreads to the brain is very serious and hard to treat. Researchers want to find out if adding an extra medication to boost the immune system's ability to fight the cancer in the brain will help patients do better than the current standard treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with melanoma that has spread to the brain
your melanoma has a specific genetic change called BRAF-V600 mutation, confirmed by lab testing
you have at least one measurable tumor in your brain (at least 0.5 cm in size) that either hasn't been treated with radiation or has grown back after radiation
you have had an MRI scan of your brain within the last 28 days showing the brain metastases
you are able to swallow pills and your blood counts and organ function are within acceptable ranges

You likely don't qualify if…

you have melanoma that started in the eye (uveal melanoma)
you cannot swallow or keep down oral medications
you have very low blood counts or severely impaired liver or kidney function
you are taking more than 8 mg of dexamethasone (a steroid) per day, or your dose was increased within the last 7 days

What participation looks like

If you enroll, you will be randomly assigned to one of two treatment groups. One group takes two pills by mouth daily plus an intravenous infusion once a month; the other group receives two intravenous infusions, with one happening every 3 weeks for the first 4 cycles, then every 4 weeks. You will continue treatment as long as your cancer is not growing and you are tolerating the medication well. Throughout the study, you will have regular appointments for blood tests, imaging scans of your brain and body, and check-ins to monitor how you are responding and any side effects.

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

Two drug combinations for melanoma that has spread to the brain

What is this trial?

Do you qualify?

What participation looks like

Trial locations(331 sites)