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
NCT ID: NCT03016312
Last Updated: 2024-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
759 participants
INTERVENTIONAL
2017-01-10
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab + Enzalutamide
Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
Enzalutamide
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Enzalutamide
Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Enzalutamide
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Interventions
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Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
Enzalutamide
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute; Division of Medical Oncology
Pittsburgh, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Charleston Oncology, P .A
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
Texas Oncology-Tyler
Irving, Texas, United States
Virginia Cancer Specialists - Alexandria
Alexandria, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Eastern Health; Cancer Services
Box Hill, New South Wales, Australia
Concord Repatriation General Hospital; Concord Cancer Centre
Concord, New South Wales, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Royal Brisbane & Women's Hosp; Cancer Care Serv
Herston, Queensland, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia
Monash Medical Centre; Oncology
Clayton, Victoria, Australia
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, , Austria
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz, , Austria
Medizinische Universität Wien; Universitätsklinik für Urologie
Vienna, , Austria
Onze Lieve Vrouwziekenhuis Aalst
Aalst, , Belgium
UZ Gent
Ghent, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Greenfield Park, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke, Quebec, Canada
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
Québec, , Canada
Friendship Hospital, Capital Medical University
Beijing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Aalborg Universitetshospital; Onkologisk Afdeling
Aalborg, , Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, , Denmark
Institut Sainte-Catherine; Oncologie
Avignon, , France
Centre Francois Baclesse; Oncologie
Caen, , France
Hopital Louis Pasteur; Medecine B
Colmar, , France
Centre Oscar Lambret; Chir Cancerologie General
Lille, , France
Clinique Chenieux; Oncology
Limoges, , France
Hopital Saint Louis, Service D Oncologie Medicale
Paris, , France
Hopital d'Instruction des Armees de Begin
Saint-Mandé, , France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
Hanover, , Germany
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Münster, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, , Germany
Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm
Würselen, , Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens, , Greece
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens, , Greece
Athens Medical Center; Dept. of Oncology
Athens, , Greece
IASO General Hospital of Athens
Athens, , Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, , Greece
University Hospital of Patras Medical Oncology
Pátrai, , Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, , Greece
Semmelwies University of Medicine; Urology Dept.
Budapest, , Hungary
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, , Hungary
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Apulia, Italy
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli, Campania, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Rome, Lazio, Italy
IRCCS AOU San Martino - IST; Oncologia Medica 1
Genoa, Liguria, Italy
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
Cremona, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Milan, Lombardy, Italy
Ospedale Area Aretina Nord; U.O.C. Oncologia
Arezzo, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padua, Veneto, Italy
Nagoya City University Hospital
Aichi, , Japan
National Cancer Center East
Chiba, , Japan
Toho University Sakura Medical Center
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Nara Medical University Hospital
Nara, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Kansai Medical University Hospital
Osaka, , Japan
Toranomon Hospital
Tokyo, , Japan
The Jikei University Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Woj. Wielospec. Centrum Onkologii i Traumatologii
?ód?, , Poland
Medical University of Bialystok; Oncology clinic
Bialystok, , Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, , Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, , Poland
Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
Warsaw, , Poland
Wojewodzki Szpital; Specjalistyczny ul.
Wroclaw, , Poland
Russian Scientific Center of Roentgenoradiology
Moscow, Moscow Oblast, Russia
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Moscow Oblast, Russia
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, Sankt-Peterburg, Russia
National Cancer Center
Goyang-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Insititut Catala D'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, , Spain
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
Bern, , Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
Sankt Gallen, , Switzerland
Taichung Veterans General Hospital; Division of Urology
Taichung, , Taiwan
National Taiwan University Hospital, Department of Urology
Taipei, , Taiwan
TAIPEI VETERANS GENERAL HOSPITAL, Urology
Taipei, , Taiwan
Chang Gung Memorial Hospital-LinKou; Urology
Taoyuan District, , Taiwan
Royal Blackburn Hospital
Blackburn, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Barts and the London NHS Trust.
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital; Institute of Cancer Research
Sutton, , United Kingdom
Countries
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References
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Powles T, Yuen KC, Gillessen S, Kadel EE 3rd, Rathkopf D, Matsubara N, Drake CG, Fizazi K, Piulats JM, Wysocki PJ, Buchschacher GL Jr, Alekseev B, Mellado B, Karaszewska B, Doss JF, Rasuo G, Datye A, Mariathasan S, Williams P, Sweeney CJ. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Nat Med. 2022 Jan;28(1):144-153. doi: 10.1038/s41591-021-01600-6. Epub 2022 Jan 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-003092-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO39385
Identifier Type: -
Identifier Source: org_study_id
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