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Trial ID CA115-001  |   NCT05543629

A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

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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 BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    1. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
      1. Participants must have a life expectancy of at least 3 months at the time of first dose.

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
          1. Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
            1. Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply.
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Part A: BMS-986442 + Nivolumab

              ASSIGNED INTERVENTION
              • Biological: BMS-986442, Nivolumab

              Study Arms

              Experimental: Part B1: BMS-986442 + Nivolumab

              ASSIGNED INTERVENTION
              • Biological: BMS-986442, Nivolumab

              Study Arms

              Experimental: Part B2: BMS-986442 + Nivolumab

              ASSIGNED INTERVENTION
              • Biological: BMS-986442, Nivolumab

              Study Arms

              Experimental: Part C: BMS-986442 + Nivolumab + Docetaxel

              ASSIGNED INTERVENTION
              • Biological: BMS-986442, Nivolumab
              • Drug: Docetaxel

              Study Arms

              Experimental: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed

              ASSIGNED INTERVENTION
              • Biological: BMS-986442, Nivolumab
              • Drug: Carboplatin, Pemexetred

              Study Arms

              Experimental: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel

              ASSIGNED INTERVENTION
              • Biological: BMS-986442, Nivolumab
              • Drug: Carboplatin, Paclitaxel

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