rechARge / CA071-1000
rechARge / CA071-1000: 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 summary:
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 comparator arm (investigator’s choice).
Receptor status / problem studied:
Inclusion criteria
1) Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
2) 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).
3) Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory – Short Form (BPI-SF) that must be < 4.
4) Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
Exclusion criteria
1) Participants must not have impaired cardiac function or clinically significant cardiac disease.
2) Participants must not have any brain metastasis.
3) Participants must not have any liver metastasis.
4) Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
5) Other protocol-defined Inclusion/Exclusion criteria apply.
Trial Title
rechARge / CA071-1000
Diagnosis
Prostate cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III