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

Recruiting at 107 trial locations

Overseen By First line of the email MUST contain NCT# and Site #.

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: CNS tumors, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately up to 3 years

1499 Participants Needed

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986016 alone or in combination with nivolumab for the treatment of advanced solid tumors

Approximately up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986016
• Nivolumab
• Relatlimab

Trial Overview The 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

Group I: Relatlimab + Nivolumab Experimental Treatment 2 Interventions

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

Group II: Relatlimab Experimental Treatment 1 Intervention

Relatlimab (BMS-986016) specified dose on specified days

Group III: BMS-986213 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania