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

Titre officiel

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

Sommaire:

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.

Description de l'essai

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)

• 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

Voir cet essai sur ClinicalTrials.gov