An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Official Title

A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

Summary:

The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR)
• Prostate-specific antigen response rate (RR-PSA)

• Radiographic progression-free survival (rPFS)
• Time to response (TTR)
• Duration of response (DOR)
• Time to prostate-specific antigen progression (TTP-PSA)
• Overall Survival (OS)
• Incidence of adverse events (AEs)
• Incidence of serious adverse events (SAEs)
• Incidence of AEs leading to discontinuation
• Incidence of immune-mediated AEs
• Incidence of deaths
• Incidence of Laboratory Abnormalities
• Number of clinically significant changes in lab assessment of blood
• Number of clinically significant changes in lab assessment of blood serum

View this trial on ClinicalTrials.gov