Nivolumab for Melanoma Prevention
(CheckMate76K Trial)

Recruiting in Palo Alto (17 mi)

+299 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing if nivolumab can help prevent melanoma from returning in patients who have had their cancer surgically removed but are at high risk for it coming back. Nivolumab boosts the immune system to fight any remaining cancer cells. Nivolumab is used for the treatment of malignant melanoma and has shown promising anticancer activity in various cancers.

Eligibility Criteria

This trial is for adults and kids who've had surgery to remove Stage IIB/C melanoma and are at high risk of it coming back. They should be in good physical shape (ECOG 0 or 1), have not been treated for melanoma before, and can't be pregnant or nursing. People with a history of certain types of melanoma, autoimmune diseases, allergies to the drug's ingredients, or previous treatments targeting immune checkpoints cannot join.

Inclusion Criteria

I am fully active or can carry out light work.

I was diagnosed with Stage IIB/C melanoma that was surgically removed.

I have never been treated for melanoma.

+1 more

Exclusion Criteria

I have been treated with specific immune system targeting drugs before.

You have a known or suspected ongoing autoimmune disease.

Known history of allergy or hypersensitivity to study drug components

+2 more

Participant Groups

The study is testing if Nivolumab, an immunotherapy drug, can prevent melanoma from returning after surgery better than a placebo (a treatment with no active drug). Participants will randomly receive either Nivolumab or the placebo to compare their effectiveness.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NivolumabExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention