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  • NCT07325136

Recruiting

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 - CA258-0001

Updated: 17 February, 2026   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
Print this page CA258-0001
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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 7

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A: BMS-986525 Monotherapy Dose Escalation
Drug: BMS-986525
Experimental: Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation
Drug: BMS-986525, Nivolumab
Experimental: Part 2A: BMS-986525 Monotherapy Dose Expansion
Drug: BMS-986525
Experimental: Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion
Drug: BMS-986525, Nivolumab

Key Eligibility Criteria

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.

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001