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Trial ID CA258-0001  |   NCT07325136

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

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 7
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC).
    1. Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines.
      1. 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
        1. (L)1 therapy.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants must not have any untreated CNS metastases.
            1. Participants must not have an active, known or suspected autoimmune disease.
              1. Participants must not have had a prior organ or tissue allograft.
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part 1A: BMS-986525 Monotherapy Dose Escalation

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986525

                  Study Arms

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

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986525, Nivolumab

                  Study Arms

                  Experimental: Part 2A: BMS-986525 Monotherapy Dose Expansion

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986525

                  Study Arms

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

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986525, Nivolumab
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