BMS-986525 + Nivolumab for Small Cell Lung Cancer

Not yet recruiting at 10 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Untreated CNS metastases, Autoimmune disease, Prior allograft, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Nivolumab in participants with Relapsed/Refractory Small Cell Lung Cancer

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with relapsed/refractory small cell lung cancer who have already tried at least one platinum-based chemotherapy. It's open to those who can't get or haven't had success with anti-PD-(L)1 therapy, which is a type of immunotherapy.

Inclusion Criteria

I have undergone at least one treatment with platinum-based chemotherapy.

My small cell lung cancer has come back or didn't respond to treatment.

I cannot use or have no access to standard anti-PD-(L)1 therapy for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986525 alone or in combination with Nivolumab in dose escalation and expansion phases

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986525
• Nivolumab

Trial Overview

The study tests the safety and how well patients tolerate BMS-986525 alone and when combined with Nivolumab, another immunotherapy drug. The goal is to see if these treatments are safe for people whose lung cancer has come back or hasn't responded to other treatments.

How Is the Trial Designed?

Group I: Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion Experimental Treatment 2 Interventions

Group II: Part 2A: BMS-986525 Monotherapy Dose Expansion Experimental Treatment 1 Intervention

Group III: Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation Experimental Treatment 2 Interventions

Group IV: Part 1A: BMS-986525 Monotherapy Dose Escalation 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