Subcutaneous vs Intravenous Nivolumab + Relatlimab for Melanoma

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing two injection methods for cancer treatment to see which one patients prefer and to ensure they are safe. The treatments help the immune system attack cancer cells.

Eligibility Criteria

This trial is for adults with melanoma, either metastatic without prior treatment or resected and confirmed disease-free within the last 12 weeks. Participants should have low disability and be at intermediate to advanced risk. Those with brain cancer treated by radiation, eye/mucous membrane cancers, autoimmune diseases, or on steroids/immunosuppressants cannot join.

Inclusion Criteria

I have melanoma that is either untreated and metastatic, or was fully removed by surgery within the last 12 weeks and I am currently cancer-free.

My melanoma is advanced or at risk of becoming advanced, but I have low disability.

Exclusion Criteria

You do not have any autoimmune disease.

I am not currently taking steroids for inflammation or drugs that weaken my immune system.

I do not have cancer in my eyes or mucous membranes.

+1 more

Participant Groups

The study evaluates patient preference between subcutaneous (under the skin) injections versus intravenous (into a vein) administration of Nivolumab alone or combined with Relatlimab. It also examines safety related to switching from IV to SC delivery.

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Resected MelanomaExperimental Treatment2 Interventions

Group II: Cohort 1: Metastatic MelanomaExperimental Treatment2 Interventions