Anti-LAG-3 + Anti-PD-1 Immunotherapy for Cancer

Recruiting in Palo Alto (17 mi)

+107 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with certain solid tumors (like lung, stomach, liver cancer and more) that have spread or can't be surgically removed. Participants must not have tried immuno-oncology drugs before, except for specific cases in melanoma and lung cancer. They should be relatively healthy otherwise and have at least one measurable tumor.

Inclusion Criteria

I have specific cancer types and am new to or have specific treatment histories with immuno-oncology agents.

I have tried at least one standard treatment without success or could not tolerate it.

At least 1 lesion with measurable disease at baseline

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Exclusion Criteria

My only active cancer is in my brain.

I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.

My cancer has spread to my brain and is not under control.

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Treatment Details

Interventions

BMS-986016 (Monoclonal Antibodies)
Nivolumab (Monoclonal Antibodies)
Relatlimab (Monoclonal Antibodies)

Trial OverviewThe study tests BMS-986016 alone or combined with nivolumab to see how safe they are and how well they work against various advanced cancers. It's looking at different doses to find the right amount that's effective but also tolerable.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Relatlimab + NivolumabExperimental Treatment2 Interventions

Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days

Group II: RelatlimabExperimental Treatment1 Intervention

Relatlimab (BMS-986016) specified dose on specified days

Group III: BMS-986213Experimental Treatment1 Intervention

Relatlimab (BMS-986016) + Nivolumab (BMS-936558)