Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Recruiting Study icon

Recruiting

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

Summary

  • Phase 3
  • Male Gender icon
  • 18+
    Age Range
  • 164
    Locations
  • BMS Recruiting Study icon
    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.

print Print
email Email

Nearest Recruiting Site

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
                      Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility
                      Check Your Eligibility
                      Answer some questions about Your health to see if you may match to this trial
                      Match to a Trial
                      If you are a match, click on the study to see the list of study site locations
                      Select a Study Site Location
                      Select a study site location that is convenient for you
                      Register
                      Provide your contact details for the study site to connect with you.

                      Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you