A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
Part of paid clinical trials in Duarte, California.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT03016312
- Phase
- PHASE3
- Status
- Completed
Conditions
- Prostatic Neoplasms, Castration-Resistant
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGAtezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
- Enzalutamide — DRUGEnzalutamide capsules will be administered orally at a dose of 160 mg daily.
Study Details
This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.
Key Dates
- Start date
- Jan 10, 2017
- Status verified
- Aug 2024
- Primary completion
- Jun 24, 2019
- Completion
- Dec 20, 2022
Study Design
- Enrollment
- 759 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Atezolizumab + EnzalutamideParticipants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
- Active Comparator: EnzalutamideParticipants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Primary Outcome Measure
Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 42 months) ]
Locations (39)
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