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Trial ID CA071-1000  |   NCT06764485

A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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Summary

  • Phase 3
  • Male Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
    1. Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
      1. Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory
        1. Short Form (BPI-SF) that must be < 4.
          1. Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

            Exclusion Criteria

            Exclusion Criteria Icon
            • Participants must not have impaired cardiac function or clinically significant cardiac disease.
              1. Participants must not have any brain metastasis.
                1. Participants must not have any liver metastasis.
                  1. Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Active Comparator: Part 1: Comparator 1

                      ASSIGNED INTERVENTION
                      • Drug: Enzalutamide, Abiraterone, Predinsone/Prednisolone

                      Study Arms

                      Active Comparator: Part 1: Comparator 2

                      ASSIGNED INTERVENTION
                      • Drug: Docetaxel, Predinsone/Prednisolone

                      Study Arms

                      Experimental: Part 1: Dose 1

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986365

                      Study Arms

                      Experimental: Part 1: Dose 2

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986365

                      Study Arms

                      Active Comparator: Part 2: Comparator 1

                      ASSIGNED INTERVENTION
                      • Drug: Enzalutamide, Abiraterone, Predinsone/Prednisolone

                      Study Arms

                      Active Comparator: Part 2: Comparator 2

                      ASSIGNED INTERVENTION
                      • Drug: Docetaxel, Predinsone/Prednisolone

                      Study Arms

                      Experimental: Part 2: Dose Selected

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986365

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