BMS-986258 + Nivolumab for Cancer

Recruiting at 33 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Must not be taking: Cytotoxic agents

Disqualifiers: Autoimmune disease, other malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

92 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with certain advanced cancers (kidney, colorectal, lung, head and neck, or triple-negative breast cancer) that have spread or can't be removed by surgery. Participants must have tried at least one standard treatment without success and should be in good physical condition. Women of childbearing potential must agree to use contraception.

Inclusion Criteria

I have one of the specified cancers that can't be removed or has spread, with measurable disease.

My cancer returned or worsened after at least one standard treatment.

Women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

It's been over 4 weeks since my last cancer treatment.

I have an autoimmune disease.

I have another cancer that needs treatment at the same time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986258 alone or in combination with Nivolumab to assess safety and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986258
• Nivolumab

Trial Overview The study is testing the safety and tolerability of BMS-986258 alone and when combined with Nivolumab in treating advanced cancers. It aims to see how well these therapies work on their own or together against different solid tumors.

Participant Groups

Group I: Part C Cohort Expansion: BMS-986258 + nivolumab Experimental Treatment 2 Interventions

Group II: Part B Dose Escalation: BMS-986258 + nivolumab Experimental Treatment 2 Interventions

Group III: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) Experimental Treatment 2 Interventions

Group IV: Part A Dose Escalation: BMS-986258 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