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

NCT ID: NCT07325136

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-18

Study Completion Date

2029-04-24

Brief Summary

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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

Detailed Description

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Conditions

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Relapsed/Refractory Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: BMS-986525 Monotherapy Dose Escalation

Group Type EXPERIMENTAL

BMS-986525

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986525

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Part 2A: BMS-986525 Monotherapy Dose Expansion

Group Type EXPERIMENTAL

BMS-986525

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

BMS-986525

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986525

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Opdivo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0011

Detroit, Michigan, United States

Site Status

Local Institution - 0026

Buffalo, New York, United States

Site Status

Local Institution - 0005

Durham, North Carolina, United States

Site Status

Local Institution - 0004

Cleveland, Ohio, United States

Site Status

Local Institution - 0006

Nashville, Tennessee, United States

Site Status

Local Institution - 0001

Rozzano, Milano, Italy

Site Status

Local Institution - 0020

Hirakata, Osaka, Japan

Site Status

Local Institution - 0018

Chuo-ku, Tokyo, Japan

Site Status

Local Institution - 0023

Timișoara, Timiș County, Romania

Site Status

Local Institution - 0003

Craiova, , Romania

Site Status

Local Institution - 0009

Madrid, , Spain

Site Status

Countries

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United States Italy Japan Romania Spain

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Site 0011

Role: primary

Site 0026

Role: primary

Site 0005

Role: primary

Site 0004

Role: primary

Site 0006

Role: primary

Site 0001

Role: primary

Site 0020

Role: primary

Site 0018

Role: primary

Site 0023

Role: primary

Site 0003

Role: primary

Site 0009

Role: primary

Related Links

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Other Identifiers

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2025-524090-16

Identifier Type: OTHER

Identifier Source: secondary_id

CA258-0001

Identifier Type: -

Identifier Source: org_study_id

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