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

Completed · Phase 3

Conditions studied: Prostatic Neoplasms, Castration-Resistant

In brief

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 facts

Study ID

NCT03016312

Run by

Hoffmann-La Roche

People needed

759

Starts

2017-01-10

Expected to finish

2022-12-20

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than or equal to (>/=) 3 months
• Histologically confirmed adenocarcinoma of the prostate
• Known castrate-resistant disease with serum testosterone level less than or equal to (</=) 50 nanograms per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study
• Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration
• One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen
• Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate cancer
• Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing
• Adequate hematologic and end organ function

You may not qualify if…

• Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM-201)
• Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment
• Treatment with abiraterone within 2 weeks prior to study treatment
• Structurally unstable bone lesions suggesting impending fracture
• Known or suspected brain metastasis or active leptomeningeal disease
• Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
• Active or history of autoimmune disease or immune deficiency
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
• History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack

Where it is running

• 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
• Miami Cancer Institute of Baptist Health, Inc. — Miami, Florida, United States
• Florida Cancer Specialist, North Region — St. Petersburg, Florida, United States
• Investigative Clin Rsch of IN — Indianapolis, Indiana, United States
• Associates in Oncology/Hematology P.C. — Rockville, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute.. — Detroit, Michigan, United States
• Nebraska Cancer Specialists; Oncology Hematology West, PC — Omaha, Nebraska, United States
• Urology Cancer Center & GU Research Network — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• MSKCC at Basking Ridge — Basking Ridge, New Jersey, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• James Cancer Hospital;Solove Research Institute — Columbus, Ohio, United States
• City of Hope Medical Grp Inc. — Duarte, California, United States

Full record on ClinicalTrials.gov

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