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 statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCelgene

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BMS-986365
  • Enzalutamide
  • Abiraterone
  • Docetaxel
  • Predinsone/Prednisolone

Treatment groups

960 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators