BMS-986416 + Nivolumab for Solid Tumors

Recruiting at 35 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cardiovascular disease, Connective tissue disease, others

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

Compensation: Varies

Number of Visits: Unknown

67 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with certain advanced solid tumors like lung, bladder, head and neck, liver, colorectal cancer or pancreatic cancer. They must have measurable disease that's resistant to standard treatments and be able to undergo biopsies. People can't join if they have serious heart issues, need blood thinners (except low-dose aspirin), or have specific connective tissue diseases.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, has spread, or come back.

My condition allows for repeated tissue sampling.

My cancer type is one of the specified: NSCLC, UC, SCCHN, HCC, MSS CRC, or PDAC.

Exclusion Criteria

I have serious heart problems that are not under control.

I have a diagnosed connective tissue disorder like Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome.

There are other requirements for participation that will be explained in the study's guidelines.

Treatment Details

Interventions

• BMS-986416
• Nivolumab

Trial Overview The study is testing BMS-986416 alone and combined with Nivolumab in patients with select solid tumors. It aims to assess the safety of these drugs, how well they're tolerated by the body, their effects on the tumor size and drug levels in the bloodstream.

Participant Groups

Group I: Part 1B: Combination Therapy (BMS-986416 + Nivolumab) Experimental Treatment 2 Interventions

Group II: Part 1A: Monotherapy (BMS-986416) Experimental Treatment 1 Intervention

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