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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07325136Sponsor: Bristol-Myers SquibbLast updated: 2026-05-07

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

Arms & interventions

  • DrugBMS-986525

    Specified dose on specified days

  • DrugNivolumab

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with adverse events (AEs)

    Time frame: Up to approximately 2 years

  • Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 2 years

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

    Time frame: Up to 21 days

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2 years

  • Number of participants with AEs leading to death

    Time frame: Up to approximately 2 years

Secondary

  • 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

  • Maximum observed concentration within a dosing interval (Cmax)

    Time frame: Up to approximately 2 years

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

    Time frame: Up to approximately 2 years

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

    Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

Local Institution - 0011

Detroit, Michigan, 48201

Not Yet Recruiting
Site 0011 · Contact

Local Institution - 0026

Buffalo, New York, 14263

Not Yet Recruiting
Site 0026 · Contact

Duke Cancer Institute

Durham, North Carolina, 27710

Recruiting
Neal Ready, Site 0005 · Contact

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Recruiting
Afshin Dowlati, Site 0004 · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Melissa Johnson, Site 0006 · Contact
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 | Cancerify