A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer

May 6, 2026 updated by: Bristol-Myers Squibb

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
  • Japan
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
  • Romania
      • Craiova, Romania, 200347
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
  • Spain
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • New York
      • Buffalo, New York, United States, 14263
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute
        • Contact:
          • Neal Ready, Site 0005
          • Phone Number: 919-681-7460
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Afshin Dowlati, Site 0004
          • Phone Number: 216-844-5432
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Scri Oncology Partners
        • Contact:
          • Melissa Johnson, Site 0006
          • Phone Number: 615-329-7274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC).
  • Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines.
  • In countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with anti-PD-(L)1 therapy, it is required that participants have progressed on, are ineligible for or not have access to an anti-PD- (L)1 therapy.

Exclusion Criteria

  • Participants must not have any untreated CNS metastases.
  • Participants must not have an active, known or suspected autoimmune disease.
  • Participants must not have had a prior organ or tissue allograft.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: BMS-986525 Monotherapy Dose Escalation
Drug: BMS-986525
Specified dose on specified days
Experimental: Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: BMS-986525
Specified dose on specified days
Experimental: Part 2A: BMS-986525 Monotherapy Dose Expansion
Drug: BMS-986525
Specified dose on specified days
Experimental: Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: BMS-986525
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with AEs leading to discontinuation
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria
Time Frame: Up to 21 days
Up to 21 days
Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Maximum observed concentration within a dosing interval (Cmax)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time of maximum observed plasma concentration within a dosing interval (Tmax)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Estimated)

April 23, 2029

Study Completion (Estimated)

April 24, 2029

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA258-0001
  • 2025-524090-16 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed/Refractory Small Cell Lung Cancer

Clinical Trials on Nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe