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NCT03016312 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 759
- Enrollment target
NCT03016312: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03016312 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 759 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03016312, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 759 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Overall Survival is defined as the time from randomization to death from any cause.
Interventions
- DRUG Atezolizumab
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 759 participants |
| Start Date | 2017-01-10 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 3 |
What the finished NCT03016312 record still lists
NCT03016312 is an interventional study that assigns participants to a tested intervention. The registered 759 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03016312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03016312 about?
NCT03016312 is a clinical study titled "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". 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...
What is the current status of trial NCT03016312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 759 participants. The study started on 2017-01-10. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03016312?
The interventions under investigation include: Atezolizumab (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT03016312?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03016312's enrollment target sits among peer trials
759 455th of 2000 higher than 1,545 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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