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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
Trial Status: active
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.
Inclusion Criteria
Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
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).
Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
Exclusion Criteria
Participants must not have impaired cardiac function or clinically significant cardiac disease.
Participants must not have any brain metastasis.
Participants must not have any liver metastasis.
Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
Other protocol-defined Inclusion/Exclusion criteria apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06764485.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
New Jersey
Turnerville
Jefferson Washington Township Hospital
Status: Active
Name Not Available
New Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not Available
New York
Mineola
NYU Langone Hospital - Long Island
Status: Active
Name Not Available
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
Fox Chase Cancer Center
Status: Active
Name Not Available
Willow Grove
Asplundh Cancer Pavilion
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Virginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not Available
The primary objective of this clinical trial is to assess the radiographic progression
free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel +
Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide.
In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose
levels, or to the active comparator arm (investigator's choice). In Part 2 of the study,
participants will be randomized 1:1 between BMS-986365 selected dose, or to the active
