Advanced Prostate Cancer, Clinical Trials, Metastatic Castration-Resistant Prostate Cancer, Phase II, Prostate Cancer

Advanced Prostate Cancer Immunotherapy Trial

Advanced Prostate Cancer Immunotherapy Trial

Advanced prostate cancer immunotherapy trial. Phase II study testing combination immune checkpoint inhibitors for metastatic castration-resistant disease.

Phase II Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

Full Title

A randomized, open-label, phase II study of dual immune checkpoint inhibition with nivolumab plus ipilimumab versus enzalutamide in patients with metastatic castration-resistant prostate cancer and DNA repair defects

Purpose

This study tests whether using two different immunotherapy drugs together works better than standard hormone therapy in men with advanced prostate cancer that has specific DNA repair problems. The combination aims to remove multiple “brakes” on the immune system to help it fight prostate cancer more effectively.

Primary Objectives

  • Compare radiographic progression-free survival between combination immunotherapy and enzalutamide
  • Evaluate overall survival and prostate-specific antigen (PSA) response rates
  • Assess safety profile of dual checkpoint inhibition in prostate cancer patients

Diseases 

  • Prostate Cancer
  • Metastatic Castration-Resistant Prostate Cancer
  • Advanced Prostate Cancer

Who Can Join this Trial

To participate in this study, you must meet ALL of the following criteria

 

  • Have histologically confirmed metastatic castration-resistant prostate cancer
  • Tumor must have DNA repair defects (BRCA1/2, ATM, CDK12, or other homologous recombination deficiency)
  • Have progressive disease despite castrate levels of testosterone
  • Have received no more than one prior novel hormonal agent for CRPC
  • Have measurable disease by RECIST v1.1 or bone scan
  • ECOG performance status 0-1
  • Age 18 years or older
  • Life expectancy ≥12 months
  • Adequate organ function including blood counts, liver, and kidney function
  • Serum testosterone <50 ng/dL
  • No symptomatic brain metastases
  • No active autoimmune disease requiring systemic immunosuppression

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