Prostate Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 (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:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

771

Study ID:

NCT03016312

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 154 Locations for this study

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City of Hope Medical Grp Inc.
Duarte California, 91010, United States
University of California San Diego
La Jolla California, 92093, United States
Kaiser Permanente San Diego - Los Angeles
Los Angeles California, 90027, United States
UC Irvine Medical Center
Orange California, 92868, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
University of Colorado; Division of Medical Oncology
Aurora Colorado, 80021, United States
Yale School of Medicine
New Haven Connecticut, 06510, United States
Stamford Hospital; BCC, MOHR
Stamford Connecticut, 06904, United States
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Miami Cancer Institute of Baptist Health, Inc.
Miami Florida, 33176, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
Investigative Clin Rsch of IN
Indianapolis Indiana, 46260, United States
Associates in Oncology/Hematology P.C.
Rockville Maryland, 20850, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute..
Detroit Michigan, 48201, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC
Omaha Nebraska, 68130, United States
Urology Cancer Center & GU Research Network
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
MSKCC at Basking Ridge
Basking Ridge New Jersey, 07920, United States
New York Oncology Hematology, P.C.
Albany New York, 12208, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45230, United States
James Cancer Hospital;Solove Research Institute
Columbus Ohio, 43210, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Allegheny Cancer Center
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Cancer Institute; Division of Medical Oncology
Pittsburgh Pennsylvania, 15232, United States
Miriam Hospital
Providence Rhode Island, 02906, United States
Charleston Oncology, P .A
Charleston South Carolina, 29414, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Texas Oncology Cancer Center
Austin Texas, 78731, United States
Texas Oncology - Methodist Dallas Cancer Center
Dallas Texas, 75203, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth Texas, 76104, United States
Texas Oncology - Memorial City
Houston Texas, 77024, United States
Texas Oncology-Tyler
Irving Texas, 75063, United States
Virginia Cancer Specialists - Alexandria
Alexandria Virginia, 22304, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Eastern Health; Cancer Services
Box Hill New South Wales, 3128, Australia
Concord Repatriation General Hospital; Concord Cancer Centre
Concord New South Wales, 2139, Australia
Macquarie University Hospital
Macquarie Park New South Wales, 2109, Australia
Royal Brisbane & Women's Hosp; Cancer Care Serv
Herston Queensland, 4029, Australia
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Monash Medical Centre; Oncology
Clayton Victoria, 3168, Australia
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz , 8036, Austria
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz , 4020, Austria
Medizinische Universität Wien; Universitätsklinik für Urologie
Wien , 1090, Austria
Onze Lieve Vrouwziekenhuis Aalst
Aalst , 9300, Belgium
UZ Gent
Gent , 9000, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Tom Baker Cancer Centre-Calgary
Calgary Alberta, T2N 4, Canada
Kingston General Hospital
Kingston Ontario, K7L 2, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Greenfield Park Quebec, J4V 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke Quebec, J1H 5, Canada
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
Quebec , G1J 1, Canada
Friendship Hospital, Capital Medical University
Beijing , 10005, China
Jiangsu Cancer Hospital
Nanjing City , 21110, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Zhongshan Hospital Fudan University
Shanghai , 20003, China
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno , 656 9, Czechia
Thomayerova nemocnice
Praha 4 - Krc , 140 5, Czechia
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg , 9000, Denmark
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C , 5000, Denmark
Institut Sainte-Catherine; Oncologie
Avignon , 84082, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
Hopital Louis Pasteur; Medecine B
Colmar , 68024, France
Centre Oscar Lambret; Chir Cancerologie General
Lille , 59000, France
Clinique Chenieux; Oncology
Limoges , 87039, France
Hopital Saint Louis, Service D Oncologie Medicale
Paris , 75475, France
Hopital d'Instruction des Armees de Begin
Saint-Mande , 94160, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse , 31059, France
Institut Gustave Roussy
Villejuif , 94805, France
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
Freiburg , 79106, Germany
Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
Hannover , 30625, Germany
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Münster , 48149, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen , 72076, Germany
Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm
Würselen , 52146, Germany
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens , 115 2, Greece
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens , 115 2, Greece
Athens Medical Center; Dept. of Oncology
Athens , 151 2, Greece
IASO General Hospital of Athens
Athens , 155 6, Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifisia , 145 6, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki , 564 2, Greece
Semmelwies University of Medicine; Urology Dept.
Budapest , 1082, Hungary
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest , 1122, Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen , 4032, Hungary
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli Campania, 80131, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena Emilia-Romagna, 41100, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma Lazio, 00152, Italy
IRCCS AOU San Martino - IST; Oncologia Medica 1
Genova Liguria, 16132, Italy
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
Cremona Lombardia, 26100, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Milano Lombardia, 20141, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari Puglia, 70124, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo Puglia, 71013, Italy
Ospedale Area Aretina Nord; U.O.C. Oncologia
Arezzo Toscana, 52100, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padova Veneto, 35128, Italy
Nagoya City University Hospital
Aichi , 467-8, Japan
National Cancer Center East
Chiba , 277-8, Japan
Toho University Sakura Medical Center
Chiba , 285-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido , 003-0, Japan
Yokohama City University Medical Center
Kanagawa , 232-0, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
Nara Medical University Hospital
Nara , 634-8, Japan
Niigata University Medical & Dental Hospital
Niigata , 951-8, Japan
Kansai Medical University Hospital
Osaka , 573-1, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
The Jikei University Hospital
Tokyo , 105-8, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Medical University of Bialystok; Oncology clinic
Bialystok , 15-02, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin , 62-50, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Kraków , 30-68, Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole , 45-06, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock , 05-40, Poland
Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
Warszawa , 02-61, Poland
Wojewodzki Szpital; Specjalistyczny ul.
Wroclaw , 51-12, Poland
Woj. Wielospec. Centrum Onkologii i Traumatologii
Łódź , 93-51, Poland
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Sankt-peterburg Leningrad, 19702, Russian Federation
Russian Scientific Center of Roentgenoradiology
Moscow , 11799, Russian Federation
P.A. Herzen Oncological Inst. ; Oncology
Moscow , 12528, Russian Federation
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Insititut Catala D'Oncologia
Hospitalet de Llobregat Barcelona, 08908, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern , 3010, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen , 9007, Switzerland
Taichung Veterans General Hospital; Division of Urology
Taichung , 407, Taiwan
National Taiwan University Hospital, Department of Urology
Taipei , 10048, Taiwan
TAIPEI VETERANS GENERAL HOSPITAL, Urology
Taipei , 11217, Taiwan
Chang Gung Memorial Hospital-LinKou; Urology
Taoyuan , 333, Taiwan
Royal Blackburn Hospital
Blackburn , BB2 3, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Barts and the London NHS Trust.
London , EC1A , United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Royal Marsden Hospital; Institute of Cancer Research
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

771

Study ID:

NCT03016312

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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