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

Description

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.

Study Start Date

January, 11 2017

Estimated Completion Date

July 2022

Interventions

  • Drug: Enzalutamide
  • Drug: Atezolizumab

Study ID

Hoffmann-La Roche -- CO39385

Status

Recruiting

Trial ID

NCT03016312

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

730

Sponsor

Hoffmann-La Roche

Inclusion Criteria

  • 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 ( 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

Exclusion Criteria

  • 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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (211)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Miriam Hospital - Providence, Rhode Island 39.6 miles None None None
Miriam Hospital - Providence, Rhode Island 39.6 miles None None None
Miriam Hospital - Providence, Rhode Island 39.6 miles None None None
Miriam Hospital - Providence, Rhode Island 39.6 miles None None None
University of Connecticut Health Center - Farmington, Connecticut 100.1 miles None None None
Yale School of Medicine - New Haven, Connecticut 119.2 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
MSKCC Commack - Commack, New York 154.4 miles None None None
MSKCC Commack - Commack, New York 154.4 miles None None None
MSKCC Commack - Commack, New York 154.4 miles None None None
MSKCC Commack - Commack, New York 154.4 miles None None None
MSKCC Commack - Commack, New York 154.4 miles None None None
MSKCC Commack - Commack, New York 154.4 miles None None None
Stamford Hospital BCC MOHR - Stamford, Connecticut 155.3 miles None None None
Stamford Hospital BCC MOHR - Stamford, Connecticut 155.3 miles None None None
Stamford Hospital BCC MOHR - Stamford, Connecticut 155.3 miles None None None
Stamford Hospital BCC MOHR - Stamford, Connecticut 155.3 miles None None None
Stamford Hospital BCC MOHR - Stamford, Connecticut 155.3 miles None None None
Stamford Hospital BCC MOHR - Stamford, Connecticut 155.3 miles None None None
MSKCC West Harrison - Harrison, New York 164.7 miles None None None
MSKCC West Harrison - Harrison, New York 164.7 miles None None None
MSKCC West Harrison - Harrison, New York 164.7 miles None None None
MSKCC West Harrison - Harrison, New York 164.7 miles None None None
MSKCC West Harrison - Harrison, New York 164.7 miles None None None
MSKCC West Harrison - Harrison, New York 164.7 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
MSKC Rockville - Rockville Centre, New York 176.5 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
MSKCC at Basking Ridge - Basking Ridge, New Jersey 214.0 miles None None None
Hunterdon Medical Center - Flemington, New Jersey 232.8 miles None None None
MD Anderson Cancer Center at Cooper - Camden, New Jersey 268.3 miles None None None
University of Pennsylvania Health System Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania Health System Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania Health System Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania Health System Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania Health System Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania Health System Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Virginia Cancer Specialists Alexandria - Alexandria, Virginia 400.6 miles None None None
Virginia Cancer Specialists Alexandria - Alexandria, Virginia 400.6 miles None None None
Virginia Cancer Specialists Alexandria - Alexandria, Virginia 400.6 miles None None None
Virginia Cancer Specialists Alexandria - Alexandria, Virginia 400.6 miles None None None
Virginia Cancer Specialists Alexandria - Alexandria, Virginia 400.6 miles None None None
Virginia Cancer Specialists Alexandria - Alexandria, Virginia 400.6 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
University of Pittsburgh Cancer Institute Division of Medical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Cancer Institute Division of Medical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Cancer Institute Division of Medical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Cancer Institute Division of Medical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Cancer Institute Division of Medical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
University of Pittsburgh Cancer Institute Division of Medical Oncology - Pittsburgh, Pennsylvania 477.2 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
James Cancer HospitalSolove Research Institute - Columbus, Ohio 641.8 miles None None None
James Cancer HospitalSolove Research Institute - Columbus, Ohio 641.8 miles None None None
James Cancer HospitalSolove Research Institute - Columbus, Ohio 641.8 miles None None None
James Cancer HospitalSolove Research Institute - Columbus, Ohio 641.8 miles None None None
James Cancer HospitalSolove Research Institute - Columbus, Ohio 641.8 miles None None None
James Cancer HospitalSolove Research Institute - Columbus, Ohio 641.8 miles None None None
Good Samaritan North Health Center - Dayton, Ohio 709.0 miles None None None
Good Samaritan North Health Center - Dayton, Ohio 709.0 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Investigative Clin Rsch of IN - Indianapolis, Indiana 804.1 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
SCRI Tennessee Oncology Chattanooga - Chattanooga, Tennessee 917.3 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
SCRI Florida Cancer Specialists East - Tallahassee, Florida 1,096.9 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Florida Cancer Specialist North Region - Saint Petersburg, Florida 1,203.3 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
SCRI Florida Cancer Specialists South - Fort Myers, Florida 1,247.9 miles None None None
HCA Midwest Division - Kansas City, Missouri 1,249.4 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Nebraska Cancer Specialists Oncology Hematology West PC - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Nebraska Cancer Specialists Oncology Hematology West PC - Omaha, Nebraska 1,292.2 miles None None None
Nebraska Cancer Specialists Oncology Hematology West PC - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Nebraska Cancer Specialists Oncology Hematology West PC - Omaha, Nebraska 1,292.2 miles None None None
Nebraska Cancer Specialists Oncology Hematology West PC - Omaha, Nebraska 1,292.2 miles None None None
Nebraska Cancer Specialists Oncology Hematology West PC - Omaha, Nebraska 1,292.2 miles None None None
Texas Oncology Methodist Dallas Cancer Center - Dallas, Texas 1,552.6 miles None None None
Texas Oncology Methodist Dallas Cancer Center - Dallas, Texas 1,552.6 miles None None None
Texas Oncology Methodist Dallas Cancer Center - Dallas, Texas 1,552.6 miles None None None
Texas Oncology Methodist Dallas Cancer Center - Dallas, Texas 1,552.6 miles None None None
Texas Oncology Methodist Dallas Cancer Center - Dallas, Texas 1,552.6 miles None None None
Texas Oncology Methodist Dallas Cancer Center - Dallas, Texas 1,552.6 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology PA Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Cancer Center - Austin, Texas 1,694.2 miles None None None
Texas Oncology Cancer Center - Austin, Texas 1,694.2 miles None None None
Texas Oncology Cancer Center - Austin, Texas 1,694.2 miles None None None
Texas Oncology Cancer Center - Austin, Texas 1,694.2 miles None None None
Texas Oncology Cancer Center - Austin, Texas 1,694.2 miles None None None
Texas Oncology Cancer Center - Austin, Texas 1,694.2 miles None None None
University of Colorado Division of Medical Oncology - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Division of Medical Oncology - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Division of Medical Oncology - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Division of Medical Oncology - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Division of Medical Oncology - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Division of Medical Oncology - Aurora, Colorado 1,759.8 miles None None None
Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada 2,380.5 miles None None None
City of Hope Medical Grp Inc - Duarte, California 2,578.2 miles None None None
City of Hope Medical Grp Inc - Duarte, California 2,578.2 miles None None None
City of Hope Medical Grp Inc - Duarte, California 2,578.2 miles None None None
City of Hope Medical Grp Inc - Duarte, California 2,578.2 miles None None None
City of Hope Medical Grp Inc - Duarte, California 2,578.2 miles None None None
City of Hope Medical Grp Inc - Duarte, California 2,578.2 miles None None None
University of California San Diego - La Jolla, California 2,581.5 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Prostate Oncology Specialists - Marina del Rey, California 2,608.1 miles None None None
University of California San Francisco Helen Diller Family Comprehensive Cancer Center - San Francisco, California 2,696.4 miles None None None
University of California San Francisco Helen Diller Family Comprehensive Cancer Center - San Francisco, California 2,696.4 miles None None None
University of California San Francisco Helen Diller Family Comprehensive Cancer Center - San Francisco, California 2,696.4 miles None None None
University of California San Francisco Helen Diller Family Comprehensive Cancer Center - San Francisco, California 2,696.4 miles None None None
University of California San Francisco Helen Diller Family Comprehensive Cancer Center - San Francisco, California 2,696.4 miles None None None
University of California San Francisco Helen Diller Family Comprehensive Cancer Center - San Francisco, California 2,696.4 miles None None None
Pacific Hematology Oncology Assocociates - San Francisco, California 2,698.0 miles None None None

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