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

NCT07325136 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA258-00012025-524090-16
• Study Type: interventional
• Target: 240
• Locations: 5 countries
• Sites: 11

Brief Summary

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

Conditions

Relapsed/Refractory Small Cell Lung Cancer

Keywords

Extensive stage-small cell lung cancer (ES-SCLC)

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events (AEs)

  Up to approximately 2 years

• Number of participants with serious adverse events (SAEs)

  Up to approximately 2 years

• Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria

  Up to 21 days

• Number of participants with AEs leading to discontinuation

  Up to approximately 2 years

• Number of participants with AEs leading to death

  Up to approximately 2 years

Secondary Outcomes (4)

• Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment

  Up to approximately 3 years

• Maximum observed concentration within a dosing interval (Cmax)

  Up to approximately 2 years

• Time of maximum observed plasma concentration within a dosing interval (Tmax)

  Up to approximately 2 years

• Area under the concentration-time curve within a dosing interval (AUC(TAU))

  Up to approximately 2 years

Study Arms (4)

Part 1A: BMS-986525 Monotherapy Dose Escalation

EXPERIMENTAL

Drug: BMS-986525

Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation

EXPERIMENTAL

Drug: BMS-986525; Drug: Nivolumab

Part 2A: BMS-986525 Monotherapy Dose Expansion

EXPERIMENTAL

Drug: BMS-986525

Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion

EXPERIMENTAL

Drug: BMS-986525; Drug: Nivolumab

Interventions

BMS-986525 DRUG

Specified dose on specified days

Part 1A: BMS-986525 Monotherapy Dose Escalation; Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation; Part 2A: BMS-986525 Monotherapy Dose Expansion; Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo

Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation; Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (11)

Local Institution - 0011

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Local Institution - 0026

Buffalo, New York, 14263, United States

NOT YET RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Local Institution - 0001

Rozzano, Milano, 20089, Italy

NOT YET RECRUITING

Local Institution - 0020

Hirakata, Osaka, 573-1191, Japan

NOT YET RECRUITING

Local Institution - 0018

Chuo-ku, Tokyo, 104-0045, Japan

NOT YET RECRUITING

Local Institution - 0023

Timișoara, Timiș County, 300239, Romania

NOT YET RECRUITING

Local Institution - 0003

Craiova, 200347, Romania

NOT YET RECRUITING

Local Institution - 0009

Madrid, 28041, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 8, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): April 23, 2029
• Study Completion (Estimated): April 24, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

RO (2); IT (1); ES (1); US (5); JP (2)