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Trial ID CA027-002  |   NCT03400332

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced 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 investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
    1. At least 1 lesion accessible for biopsy
      1. Eastern Cooperative Oncology Group Performance Status of 0 or 1

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
          1. Participants with active, known or suspected autoimmune disease
            1. Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
              1. Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
                1. Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other protocol defined inclusion/exclusion criteria could apply
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part 1A: BMS-986253 + nivolumab

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986253
                  • Biological: Nivolumab

                  Study Arms

                  Experimental: Part 1B: BMS-986253 + nivolumab

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986253
                  • Biological: Nivolumab

                  Study Arms

                  Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986253
                  • Biological: Nivolumab, Ipilimumab

                  Study Arms

                  Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986253
                  • Biological: Nivolumab, Ipilimumab

                  Study Arms

                  Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab

                  ASSIGNED INTERVENTION
                  • Biological: Nivolumab, Ipilimumab
                  • Other: Placebo

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