RecruitingPhase 1Phase 2NCT07325136

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

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


Sponsor

Bristol-Myers Squibb

Enrollment

240 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interventions

DRUGBMS-986525

Specified dose on specified days

DRUGNivolumab

Specified dose on specified days


Locations(11)

Local Institution - 0011

Detroit, Michigan, United States

Local Institution - 0026

Buffalo, New York, United States

Local Institution - 0005

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Local Institution - 0001

Rozzano, Milano, Italy

Local Institution - 0020

Hirakata, Osaka, Japan

Local Institution - 0018

Chuo-ku, Tokyo, Japan

Local Institution - 0023

Timișoara, Timiș County, Romania

Local Institution - 0003

Craiova, Romania

Local Institution - 0009

Madrid, Spain

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NCT07325136