Data from clinicaltrials.gov - Curated by EPG Health - Last updated 30 September 2019

The purpose of this study is to test the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation

purpose

The purpose of this study is to test the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 984 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Estimated Study Start Date: December 16, 2019
Estimated Primary Completion Date: February 20, 2023
Estimated Study Completion Date: May 14, 2024

Arms:
- Experimental:
Arm A: (nivolumab + docetaxel + prednisone)
- Active Comparator: Arm B: (placebo + docetaxel + prednisone)

Category Value
Date last updated at source 23-Sep-19
Study type(s) Interventional
Expected enrolment 984
Study start date 16-Dec-19
Estimated primary completion date 20-Feb-23

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