Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

Official Title

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

Summary:

The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior docetaxel-containing regimen.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) in Cohort B, C, and Cohort D - Part 2 period
• Objective Response Rate (ORR) in Cohort D - Part 1 period
• Radiographic Progression-Free Survival (rPFS)

• Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, and Cohort D - Part 2 period
• Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D - Part 1 period
• Overall Survival (OS) in Cohort B, C, and Cohort D - Part 2 period
• Overall Survival (OS) in Cohort D - Part 1 period
• Incidence of Adverse Events (AEs)
• Incidence of Serious Adverse Events (SAEs)
• Incidence of Adverse Events (AEs) leading to discontinuation
• Incidence of Immune-mediated Adverse Events (IMAEs)
• Incidence of deaths
• Incidence of laboratory abnormalities: Hematology
• Incidence of laboratory abnormalities: Clinical Chemistry
• Incidence of laboratory abnormalities: Coagulation
• Incidence of laboratory abnormalities: Liver function
• Incidence of laboratory abnormalities: Thyroid function
• Incidence of laboratory abnormalities: Adrenal function
• Incidence of laboratory abnormalities: Renal function
• Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF)
• Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L)
• Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire
• Prostate Specfic Antigen (PSA) Response Rate

View this trial on ClinicalTrials.gov