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Trial ID CA120-1001  |   NCT05888831

A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
    1. Part 1A may have a solid malignancy of any histology.
      1. Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
        1. Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
          1. Tumor biopsy must be obtained for all participants (unless medically precluded).

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD
              1. 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
                1. Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
                  1. Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. Other protocol-defined criteria may apply.
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Dose Escalation: BMS-986449 + nivolumab

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986449, Nivolumab

                    Study Arms

                    Experimental: Dose Escalation: BMS-986449 monotherapy

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986449

                    Study Arms

                    Experimental: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986449

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