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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 (IMbassador250)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03016312
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms, Castration-Resistant Drug: Atezolizumab Drug: Enzalutamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 771 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : March 21, 2020
Estimated Study Completion Date : March 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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).
Drug: Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: Tecentriq®

Drug: Enzalutamide
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Other Name: Xtandi®

Active Comparator: Enzalutamide
Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Drug: Enzalutamide
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Other Name: Xtandi®

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 42 months) ]

Secondary Outcome Measures :
  1. Percentage of Participants who Survived at Month 12 and 24 [ Time Frame: Months 12, 24 ]
  2. Time to First Symptomatic Skeletal Event (SSE) [ Time Frame: Baseline up to end of study (up to approximately 42 months) ]
  3. Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria [ Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months) ]
  4. Percentage of Participants Who are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria [ Time Frame: Months 6, 12 ]
  5. Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline [ Time Frame: Baseline until disease progression (up to approximately 42 months) ]
  6. Time to PSA Progression, Assessed as per PCWG3 Criteria [ Time Frame: Baseline until disease progression (up to approximately 42 months) ]
  7. Percentage of Participant With Objective Response, as Determined by the Investigator Through use of PCWG3 Criteria [ Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months) ]
  8. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to end of study (up to approximately 42 month ]
  9. Minimum Observed Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months) ]
  10. Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months) ]
  11. Plasma Concentration of Enzalutamide [ Time Frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8 ]
  12. Plasma Concentration of N-Desmethyl Enzalutamide [ Time Frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8 ]
  13. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03016312

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United States, California
City of Hope Medical Grp Inc.
Duarte, California, United States, 91010
University of California San Diego
La Jolla, California, United States, 92093
Kaiser Permanente San Diego - Los Angeles
Los Angeles, California, United States, 90027
UC Irvine Medical Center
Orange, California, United States, 92868
Pacific Hematology Oncology Assocociates
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado; Division of Medical Oncology
Aurora, Colorado, United States, 80021
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Stamford Hospital; BCC, MOHR
Stamford, Connecticut, United States, 06904
United States, Florida
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States, 33916
Miami Cancer Institute of Baptist Health, Inc.
Miami, Florida, United States, 33176
Florida Cancer Specialist, North Region
Saint Petersburg, Florida, United States, 33705
United States, Indiana
Investigative Clin Rsch of IN
Indianapolis, Indiana, United States, 46260
United States, Maryland
Associates in Oncology/Hematology P.C.
Rockville, Maryland, United States, 20850
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute..
Detroit, Michigan, United States, 48201
United States, Nebraska
Nebraska Cancer Specialists; Oncology Hematology West, PC
Omaha, Nebraska, United States, 68130
Urology Cancer Center & GU Research Network
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New Jersey
MSKCC at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45230
James Cancer Hospital;Solove Research Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Cancer Institute; Division of Medical Oncology
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Charleston Oncology, P .A
Charleston, South Carolina, United States, 29414
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
United States, Texas
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, United States, 75203
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology - Memorial City
Houston, Texas, United States, 77024
Texas Oncology-Tyler
Irving, Texas, United States, 75063
United States, Virginia
Virginia Cancer Specialists - Alexandria
Alexandria, Virginia, United States, 22304
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Australia, New South Wales
Eastern Health; Cancer Services
Box Hill, New South Wales, Australia, 3128
Concord Repatriation General Hospital; Concord Cancer Centre
Concord, New South Wales, Australia, 2139
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Australia, Queensland
Royal Brisbane & Women's Hosp; Cancer Care Serv
Herston, Queensland, Australia, 4029
Australia, South Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Monash Medical Centre; Oncology
Clayton, Victoria, Australia, 3168
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, Austria, 8036
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz, Austria, 4020
Medizinische Universität Wien; Universitätsklinik für Urologie
Wien, Austria, 1090
Onze Lieve Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
UZ Gent
Gent, Belgium, 9000
CHU Sart-Tilman
Liège, Belgium, 4000
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V6
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1Z5
Canada, Quebec
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Greenfield Park, Quebec, Canada, J4V 2H1
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6
CHUS (Centre Hospitalier Universitaire de Sherbrooke)
Sherbrooke, Quebec, Canada, J1H 5N4
Friendship Hospital, Capital Medical University
Beijing, China, 100050
Jiangsu Cancer Hospital
Nanjing, China, 210009
Fudan University Shanghai Cancer Center
Shanghai City, China, 200120
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 656 91
Thomayerova nemocnice
Praha 4 - Krc, Czechia, 140 59
Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
Aalborg, Denmark, 9000
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, Denmark, 2730
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, Denmark, 5000
Institut Sainte-Catherine; Oncologie
Avignon, France, 84082
Centre Francois Baclesse; Oncologie
Caen, France, 14076
Hopital Louis Pasteur; Medecine B
Colmar, France, 68024
Centre Oscar Lambret; Chir Cancerologie General
Lille, France, 59000
Clinique Chenieux; Oncology
Limoges, France, 87039
Hopital Saint Louis, Service D Oncologie Medicale
Paris, France, 75475
Hopital d'Instruction des Armees de Begin
Saint-Mande, France, 94160
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France, 94805
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
Freiburg, Germany, 79106
Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
Hannover, Germany, 30625
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Münster, Germany, 48149
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, Germany, 72076
Urologisches Zentrum Euregio; Urologische Praxis am Wasserturm
Würselen, Germany, 52146
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens, Greece, 115 22
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens, Greece, 115 28
Athens Medical Center; Dept. of Oncology
Athens, Greece, 151 25
IASO General Hospital of Athens
Athens, Greece, 155 62
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifisia, Greece, 145 64
University Hospital of Patras Medical Oncology
Patras, Greece, 265 04
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, Greece, 564 29
Semmelwies University of Medicine; Urology Dept.
Budapest, Hungary, 1082
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest, Hungary, 1122
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, Hungary, 4032
Napoli, Campania, Italy, 80131
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy, 41100
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma, Lazio, Italy, 00152
IRCCS AOU San Martino - IST; Oncologia Medica 1
Genova, Liguria, Italy, 16132
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
Cremona, Lombardia, Italy, 26100
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
Milano, Lombardia, Italy, 20141
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Puglia, Italy, 70124
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Puglia, Italy, 71013
Ospedale Area Aretina Nord; U.O.C. Oncologia
Arezzo, Toscana, Italy, 52100
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padova, Veneto, Italy, 35128
Nagoya City University Hospital
Aichi, Japan, 467-8602
National Cancer Center East
Chiba, Japan, 277-8577
Toho University Sakura Medical Center
Chiba, Japan, 285-8741
Kyushu University Hospital
Fukuoka, Japan, 812-8582
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Yokohama City University Medical Center
Kanagawa, Japan, 232-0024
Kitasato University Hospital
Kanagawa, Japan, 252-0375
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Nara Medical University Hospital
Nara, Japan, 634-8522
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Kansai Medical University Hospital
Osaka, Japan, 573-1191
Toranomon Hospital
Tokyo, Japan, 105-8470
The Jikei University Hospital
Tokyo, Japan, 105-8471
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Medical University of Bialystok; Oncology clinic
Bialystok, Poland, 15-027
Przychodnia Lekarska "KOMED", Roman Karaszewski
Konin, Poland, 625000
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Kraków, Poland, 30-688
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole, Poland, 45-060
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, Poland, 05-400
Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
Warszawa, Poland, 02-616
Wojewodzki Szpital; Specjalistyczny ul.
Wroclaw, Poland, 51-124
Woj. Wielospec. Centrum Onkologii i Traumatologii
Łódź, Poland, 93-513
Russian Federation
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Sankt-peterburg, Leningrad, Russian Federation, 197022
Russian Scientific Center of Roentgenoradiology
Moscow, Russian Federation, 117997
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Russian Federation, 125284
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Insititut Catala D'Oncologia
Hospitalet de Llobregat, Barcelona, Spain, 08908
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain, 14004
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, Switzerland, 3010
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen, Switzerland, 9007
Taichung Veterans General Hospital; Division of Urology
Taichung, Taiwan, 407
National Taiwan University Hospital, Department of Urology
Taipei, Taiwan, 10048
Taipei, Taiwan, 11217
Chang Gung Memorial Hospital-LinKou; Urology
Taoyuan, Taiwan, 333
United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 3HH
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Barts and the London NHS Trust.
London, United Kingdom, EC1A 7BE
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital; Institute of Cancer Research
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT03016312    
Other Study ID Numbers: CO39385
2016-003092-22 ( EudraCT Number )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Steroid Synthesis Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists