Testing a new melanoma medication against a standard treatment

Plain-English translation of NCT07221734 on ClinicalTrials.gov ↗ · Source last updated January 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 trial is testing MB11, a new version of a melanoma medication, to see if it works just as well and safely as the standard Opdivo®. About 632 people with advanced melanoma that hasn't been treated before will be randomly assigned to receive either the new medication or the standard version, and researchers will carefully track how well the treatment works and any side effects that occur.

Opdivo® is an established and effective treatment for advanced melanoma, but developing new versions of this medication could make it more accessible and affordable for patients around the world who need it.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with advanced melanoma (Stage III or IV) that has not been treated before
you weigh at least 50 kg (about 110 pounds)
your overall health and organ function (liver, kidneys, blood counts) are adequate, as shown by blood tests
you have at least one measurable tumor that can be tracked by imaging scans
you have a recent tumor tissue sample available for testing

You likely don't qualify if…

you have received other immune therapy treatments for melanoma before, even as adjuvant or preventive therapy
you have had cancer treatments with certain prohibited medications within the past year
your organ function (liver, kidney, or blood counts) is significantly impaired
you are unable or unwilling to use contraception if you are of childbearing age

What participation looks like

You would be randomly assigned to receive either the new medication or the standard version, given as an intravenous infusion. The study will include regular clinic visits for imaging scans, blood tests, and physical exams to monitor how well the treatment is working and to watch for any side effects. You'll also have a tumor tissue biopsy taken before starting treatment so researchers can study how your specific cancer responds to the medication.

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

Trial locations(19 sites)

Portugal

Site 111003, Funchal

Ukraine

Site 117015, Chernivtsi

Site 117005, Ivano-Frankivsk

Site 117002, Kyiv

Site 117006, Kyiv