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Trial ID CA043-001  |   NCT03994601

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

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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 determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
    1. Eastern Cooperative Oncology Group Performance Status of 0 or 1
      1. Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Active, known or suspected autoimmune disease
          1. Active malignancy requiring concurrent intervention
            1. Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded Other protocol-defined inclusion/exclusion criteria apply
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Arm A: BMS-986288 Monotherapy

              ASSIGNED INTERVENTION
              • Drug: BMS-986288

              Study Arms

              Experimental: Arm B: BMS-986288 in combination with Nivolumab

              ASSIGNED INTERVENTION
              • Drug: BMS-986288, Nivolumab

              Study Arms

              Experimental: Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

              ASSIGNED INTERVENTION
              • Drug: Regorafenib, BMS-986288, Nivolumab

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