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)
Secondary Outcome:
  • 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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society