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.
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 (=) 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:
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
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There are 154 Locations for this study
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90027, United States
Orange California, 92868, United States
San Francisco California, 94115, United States
Aurora Colorado, 80021, United States
New Haven Connecticut, 06510, United States
Stamford Connecticut, 06904, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33916, United States
Miami Florida, 33176, United States
Saint Petersburg Florida, 33705, United States
Indianapolis Indiana, 46260, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Omaha Nebraska, 68130, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89128, United States
Basking Ridge New Jersey, 07920, United States
Albany New York, 12208, United States
New York New York, 10032, United States
New York New York, 10065, United States
Cincinnati Ohio, 45230, United States
Columbus Ohio, 43210, United States
Hershey Pennsylvania, 17033, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Providence Rhode Island, 02906, United States
Charleston South Carolina, 29414, United States
Myrtle Beach South Carolina, 29572, United States
Chattanooga Tennessee, 37404, United States
Austin Texas, 78731, United States
Dallas Texas, 75203, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Irving Texas, 75063, United States
Alexandria Virginia, 22304, United States
Norfolk Virginia, 23502, United States
Box Hill New South Wales, 3128, Australia
Concord New South Wales, 2139, Australia
Macquarie Park New South Wales, 2109, Australia
Herston Queensland, 4029, Australia
Kurralta Park South Australia, 5037, Australia
Clayton Victoria, 3168, Australia
Graz , 8036, Austria
Linz , 4020, Austria
Wien , 1090, Austria
Aalst , 9300, Belgium
Gent , 9000, Belgium
Liège , 4000, Belgium
Calgary Alberta, T2N 4, Canada
Kingston Ontario, K7L 2, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M5G 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3T 1, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1J 1, Canada
Beijing , 10005, China
Nanjing City , 21110, China
Shanghai City , 20012, China
Shanghai , 20003, China
Brno , 656 5, Czechia
Brno , 656 9, Czechia
Praha 4 - Krc , 140 5, Czechia
Aalborg , 9000, Denmark
Herlev , 2730, Denmark
Odense C , 5000, Denmark
Avignon , 84082, France
Caen , 14076, France
Colmar , 68024, France
Lille , 59000, France
Limoges , 87039, France
Paris , 75475, France
Saint-Mande , 94160, France
Toulouse , 31059, France
Villejuif , 94805, France
Freiburg , 79106, Germany
Hannover , 30625, Germany
Münster , 48149, Germany
Tübingen , 72076, Germany
Würselen , 52146, Germany
Athens , 115 2, Greece
Athens , 115 2, Greece
Athens , 151 2, Greece
Athens , 155 6, Greece
Kifisia , 145 6, Greece
Patras , 265 0, Greece
Thessaloniki , 564 2, Greece
Budapest , 1082, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Napoli Campania, 80131, Italy
Modena Emilia-Romagna, 41100, Italy
Roma Lazio, 00152, Italy
Genova Liguria, 16132, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Bari Puglia, 70124, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Arezzo Toscana, 52100, Italy
Padova Veneto, 35128, Italy
Aichi , 467-8, Japan
Chiba , 277-8, Japan
Chiba , 285-8, Japan
Fukuoka , 812-8, Japan
Hokkaido , 003-0, Japan
Kanagawa , 232-0, Japan
Kanagawa , 252-0, Japan
Kyoto , 602-8, Japan
Nara , 634-8, Japan
Niigata , 951-8, Japan
Osaka , 573-1, Japan
Tokyo , 105-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Bialystok , 15-02, Poland
Konin , 62-50, Poland
Kraków , 30-68, Poland
Opole , 45-06, Poland
Otwock , 05-40, Poland
Warszawa , 02-61, Poland
Wroclaw , 51-12, Poland
Łódź , 93-51, Poland
Sankt-peterburg Leningrad, 19702, Russian Federation
Moscow , 11799, Russian Federation
Moscow , 12528, Russian Federation
Badalona Barcelona, 08916, Spain
Hospitalet de Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 8208, Spain
Córdoba Cordoba, 14004, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Bern , 3010, Switzerland
St. Gallen , 9007, Switzerland
Taichung , 407, Taiwan
Taipei , 10048, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Blackburn , BB2 3, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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