A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen
A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer 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 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.
Inclusion Criteria:
Exclusion Criteria:
Pittsburgh, Pennsylvania 15232, United States
Box Hill, New South Wales 3128, Australia
Concord, New South Wales 2139, Australia
Greenfield Park, Quebec J4V 2H1, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Praha 4 - Krc, 140 59, Czechia
Freiburg im Breisgau, 79106, Germany
Hanover, 30625, Germany
Athens, 115 28, Greece
Budapest, 1122, Hungary
Naples, Campania 80131, Italy
Hokkaido, 003-0804, Japan
?ód?, 93-513, Poland
Otwock, 05-400, Poland
Moscow, Moscow Oblast 117997, Russia
Moscow, Moscow Oblast 125248, Russia
Saint Petersburg, Sankt-Peterburg 197022, Russia
Bern, 3010, Switzerland