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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 759 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03016312
The ClinicalTrials.gov registry entry for NCT03016312 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 759 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03016312 reports 0 study locations.
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.
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