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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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
City of Hope Medical Grp Inc.
Duarte, California, United States
University of California San Diego
La Jolla, California, United States
Kaiser Permanente San Diego - Los Angeles
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
University of Colorado; Division of Medical Oncology
Aurora, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Stamford Hospital; BCC, MOHR
Stamford, Connecticut, United States
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton, Florida, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Start Date
January 10, 2017
Primary Completion Date
June 24, 2019
Completion Date
December 20, 2022
Last Updated
August 9, 2024
759
ACTUAL participants
Atezolizumab
DRUG
Enzalutamide
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07225946
NCT04868604
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05743621