A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

Official Title

A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

Summary:

The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.

Trial Description

Primary Outcome:

  • Number of participants with adverse events (AEs)
  • Number of deaths
  • Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3)
Secondary Outcome:
  • Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3)
  • Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR
  • Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR
  • Prostate-specific antigen response rate (PSA-RR)
  • Time to prostate-specific antigen progression (TTP-PSA) per PCWG3
  • Overall survival (OS)
  • Number of participants with adverse events (AEs)
  • Number of deaths

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society