Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate... | NCT03834493 | Trialant

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate... | NCT03834493 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization

Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)

Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)

Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)

Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization

Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom

Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active treatment in the last 3 years

Has an active autoimmune disease that has required systemic treatment in past 2 years

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications

Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules

Has an active infection (including tuberculosis) requiring systemic therapy

Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease

Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients

Has a history of seizure or any condition that may predispose to seizure

Has a history of loss of consciousness within 12 months of screening

Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit

Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)

Has history of prostate cancer progression on ketoconazole

Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate

Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor

Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer

Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC

Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization

Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization

Has received a live or live attenuated vaccine within 30 days prior to randomization

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Has a "superscan" bone scan

Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide

Has had an allogenic tissue/solid organ transplant

University of South Alabama, Mitchell Cancer Institute ( Site 0065)

Mobile, Alabama 36604, United States

Providence Medical Foundation-Oncology ( Site 0069)

Fullerton, California 92835, United States

UCLA Hematology/Oncology - Santa Monica ( Site 0081)

Los Angeles, California 90404, United States

University of Colorado Cancer Center ( Site 0022)

Aurora, Colorado 80045, United States

Smilow Cancer Hospital at Yale New Haven ( Site 0038)

New Haven, Connecticut 06513, United States

Moffitt Cancer Center ( Site 0080)

Tampa, Florida 33612, United States

Georgia Cancer Center at Augusta University ( Site 0026)

Augusta, Georgia 30912, United States

Mount Sinai Hospital ( Site 0042)

Chicago, Illinois 60608, United States

Methodist Hospitals. ( Site 0008)

Merrillville, Indiana 46410, United States

Tulane Cancer Center ( Site 0066)

New Orleans, Louisiana 70112, United States

University of Massachusetts Worcester ( Site 0053)

Worcester, Massachusetts 01655, United States

Cancer & Hematology Centers of Western Michigan ( Site 0013)

Grand Rapids, Michigan 49503, United States

Munson Medical Center ( Site 0030)

Traverse City, Michigan 49684, United States

St. Vincent Frontier Cancer Center ( Site 0016)

Billings, Montana 59102, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)

Omaha, Nebraska 68130, United States

Comprehensive Cancer Centers of Nevada ( Site 0092)

Las Vegas, Nevada 89169, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

Hackensack, New Jersey 07601, United States

Associated Medical Professionals of NY ( Site 0060)

Syracuse, New York 13210, United States

W. G. Bill Hefner VA Medical Center ( Site 0029)

Salisbury, North Carolina 28144, United States

Gabrail Cancer Center-Research ( Site 0096)

Canton, Ohio 44718, United States

Tri-State Urologic Services PSC, Inc. ( Site 0094)

Cincinnati, Ohio 45212, United States

University Hospitals Cleveland Medical Center ( Site 0036)

Cleveland, Ohio 44106, United States

Oregon Health Science University ( Site 0031)

Portland, Oregon 97239, United States

Carolina Urologic Research Center ( Site 0070)

Myrtle Beach, South Carolina 29572, United States

Inova Schar Cancer Institute ( Site 0006)

Fairfax, Virginia 22031, United States

Virginia Cancer Institute ( Site 0052)

Richmond, Virginia 23230, United States

Blue Ridge Cancer Care ( Site 0086)

Roanoke, Virginia 24014, United States

Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)

Milwaukee, Wisconsin 53226, United States

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)

Berazategui, Buenos Aires B1884BBF, Argentina

Organizacion Medica de Investigacion ( Site 1019)

CABA, Buenos Aires C1015ABO, Argentina

Instituto Medico Alexander Fleming ( Site 1010)

Ciudad Autonoma de Buenos Aires., Buenos Aires C1426ANZ, Argentina

Instituto de Investigaciones Clinicas ( Site 1000)

Mar del Plata, Buenos Aires B7600FZO, Argentina

Centro de Diagnostico Urologico ( Site 1008)

Buenos Aires, Buenos Aires F.D. C1120AAT, Argentina

Sanatorio Parque ( Site 1002)

Rosario, Santa Fe Province S2000DSV, Argentina

Instituto de Oncologia de Rosario ( Site 1015)

Rosario, Santa Fe Province S2000KZE, Argentina

Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)

Buenos Aires, C1012AAR, Argentina

Hospital Aleman ( Site 1004)

Buenos Aires, C1118AAT, Argentina

Centro Medico Dra De Salvo ( Site 1018)

Buenos Aires, C1426ABP, Argentina

CEMAIC ( Site 1014)

Córdoba, X5008HHW, Argentina

Centro Oncologico Riojano Integral ( Site 1005)

La Rioja, F5300COE, Argentina

Centro Oncologico de Integracion Regional. COIR ( Site 1007)

Mendoza, M5500AYB, Argentina

St. Vincent's Hospital ( Site 0158)

Darlinghurst, New South Wales 2010, Australia

St George Hospital ( Site 0157)

Kogarah, New South Wales 2217, Australia

Macquarie University ( Site 0151)

Macquarie University, New South Wales 2109, Australia

Port Macquarie Base Hospital ( Site 0153)

Port Macquarie, New South Wales 2444, Australia

Calvary Mater Newcastle ( Site 0148)

Waratah, New South Wales 2298, Australia

Gallipoli Medical Research Ltd ( Site 0149)

Greenslopes, Queensland 4120, Australia

Gold Coast University Hospital ( Site 0150)

Southport, Queensland 4215, Australia

Royal Adelaide Hospital ( Site 0154)

Adelaide, South Australia 5000, Australia

Monash Medical Centre ( Site 0147)

Clayton, Victoria 3168, Australia

Fiona Stanley Hospital ( Site 0162)

Perth, Western Australia 6150, Australia

Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

Linz, Upper Austria 4020, Austria

Medizinische Universität Wien ( Site 0375)

Vienna, 1090, Austria

Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)

Curitiba, Paraná 81520-060, Brazil

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)

Natal, Rio Grande do Norte 59075-740, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)

Ijuí, Rio Grande do Sul 98700-000, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

Itajaí, Santa Catarina 88301-215, Brazil

Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

São José do Rio Preto, São Paulo 15090-000, Brazil

A.C. Camargo Cancer Center ( Site 1026)

São Paulo, 01509-900, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)

São Paulo, 04014-002, Brazil

MHAT Serdika-Second Department of Medical Oncology ( Site 0505)

Sofia, Sofia (stolitsa) 1301, Bulgaria

MHAT Central Hospital ( Site 0503)

Plovdiv, 4000, Bulgaria

Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)

Plovdiv, 4004, Bulgaria

BC Cancer Victoria-Clinical Trials Unit ( Site 0111)

Victoria, British Columbia V8R 6V5, Canada

Health Sciences North ( Site 0122)

Greater Sudbury, Ontario P3E 5J1, Canada

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

Hamilton, Ontario L8V 5C2, Canada

Grand River Hospital ( Site 0120)

Kitchener, Ontario N2G 1G3, Canada

Lakeridge Health ( Site 0117)

Oshawa, Ontario L1G 2B9, Canada

Sunnybrook Research Institute ( Site 0108)

Toronto, Ontario M4N 3M5, Canada

Princess Margaret Cancer Centre ( Site 0107)

Toronto, Ontario M5G 2M9, Canada

CISSS de la Monteregie-Centre ( Site 0119)

Greenfield Park, Quebec J4V 2H1, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)

Montreal, Quebec H2X 3E4, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0103)

Québec, Quebec G1J 1Z4, Canada

CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

Rimouski, Quebec G5L 5T1, Canada

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

Sherbrooke, Quebec J1H 5N4, Canada

Centro Investigación del Cáncer James Lind ( Site 1041)

Temuco, Araucania 4800827, Chile

Rey y Oreilly Limitada ( Site 1048)

Temuco, Araucania 4810148, Chile

Fundacion Arturo Lopez Perez ( Site 1049)

Santiago, Region M. de Santiago 7500921, Chile

Pontificia Universidad Catolica de Chile ( Site 1047)

Santiago, Region M. de Santiago 8330024, Chile

Bradfordhill ( Site 1044)

Santiago, Region M. de Santiago 8420383, Chile

Oncocentro ( Site 1045)

Viña del Mar, Valparaiso 2520598, Chile

Hospital Pablo Tobon Uribe ( Site 1066)

Medellín, Antioquia 050034, Colombia

Biomelab S A S ( Site 1067)

Barranquilla, Atlántico 080001, Colombia

Clinica de la Costa S.A.S. ( Site 1073)

Barranquilla, Atlántico 080020, Colombia

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)

Bogotá, Bogota D.C. 110311, Colombia

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)

Valledupar, Cesar Department 200001, Colombia

Oncomédica S.A.S ( Site 1057)

Montería, Departamento de Córdoba 230002, Colombia

Clínica Imbanaco S.A.S ( Site 1064)

Cali, Valle del Cauca Department 760042, Colombia

Hemato Oncologos S.A. ( Site 1065)

Cali, Valle del Cauca Department 760042, Colombia

Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)

Brno, Brno-mesto 656 91, Czechia

Nemocnice AGEL Novy Jicin a.s. ( Site 1304)

Nový Jičín, Novy Jicin 741 01, Czechia

Fakultni nemocnice Olomouc ( Site 1301)

Olomouc, Olomouc Region 779 00, Czechia

C.H. de Saint Quentin ( Site 0481)

Saint-Quentin, Aisne 02321, France

Centre Jean Perrin ( Site 0434)

Clermont-Ferrand, Auvergne 63011, France

Clinique Sainte Anne ( Site 0431)

Strasbourg, Bas-Rhin 67000, France

CHU de Brest -Site Hopital Morvan ( Site 0441)

Brest, Brittany Region 29200, France

CHU Jean Minjoz ( Site 0423)

Besançon, Doubs 25000, France

Institut Bergonie ( Site 0421)

Bordeaux, Gironde 33076, France

Institut Claudius Regaud IUCT Oncopole ( Site 0418)

Toulouse, Haute-Garonne 31059, France

Hopital Foch ( Site 0428)

Suresnes, Hauts-de-Seine 92150, France

Institut Regional du Cancer de Montpellier - ICM ( Site 0443)

Montpellier, Herault 34298, France

Institut De Cancerologie De L Ouest ( Site 0448)

Saint-Herblain, Loire-Atlantique 44805, France

Centre Hospitalier Regional du Orleans ( Site 0430)

Orléans, Loiret 45100, France

Centre D Oncologie de Gentilly ( Site 0432)

Nancy, Meurthe-et-Moselle 54000, France

Centre Hospitalier de Valenciennes ( Site 0439)

Valenciennes, Nord 59300, France

C.H.U. Lyon Sud ( Site 0436)

Pierre-Bénite, Rhone 69310, France

CHU Amiens Picardie Site Sud Amiens ( Site 0438)

Amiens, Somme 80000, France

Institut Gustave Roussy ( Site 0416)

Villejuif, Val-de-Marne 94800, France

Institut Sainte Catherine ( Site 0447)

Avignon, Vaucluse 84918, France

Institut Mutualiste Montsouris ( Site 0446)

Paris, 75014, France

Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

Studienpraxis Urologie ( Site 0309)

Nürtingen, Baden-Wurttemberg 72622, Germany

Universitaetsklinik fuer Urologie ( Site 0307)

Tübingen, Baden-Wurttemberg 72076, Germany

Klinikum Rechts der Isar ( Site 0300)

Munich, Bavaria 81675, Germany

Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

Nuremberg, Bavaria 90419, Germany

Universitaetsklinikum Goettingen ( Site 0345)

Göttingen, Lower Saxony 37075, Germany

Uniklinik RWTH Aachen ( Site 0308)

Aachen, North Rhine-Westphalia 52074, Germany

Universitaetsklinikum Muenster ( Site 0320)

Münster, North Rhine-Westphalia 48149, Germany

Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

Trier, Rhineland-Palatinate 54292, Germany

Universitaetsklinikum des Saarlandes ( Site 0348)

Homburg, Saarland 66421, Germany

Universitaetsklinikum Schleswig Holstein. ( Site 0346)

Lübeck, Schleswig-Holstein 23538, Germany

Universitaetsklinikum Jena ( Site 0305)

Jena, Thuringia 07747, Germany

Charite Universitaetsmedizin Berlin ( Site 0301)

Berlin, 10117, Germany

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)

Kecskemét, Bács-Kiskun county 6000, Hungary

Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)

Győr, Győr-Moson-Sopron 9024, Hungary

Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)

Budapest, Pest County 1122, Hungary

Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)

Budapest, 1062, Hungary

Beaumont Hospital ( Site 0726)

Dublin, D09 V2N0, Ireland

Tallaght University Hospital ( Site 0730)

Dublin, D24 NROA, Ireland

Mid Western Cancer Centre ( Site 0728)

Limerick, V98F858, Ireland

HaEmek Medical Center ( Site 0548)

Afula, 1834111, Israel

Assuta Ashdod Medical Center ( Site 0550)

Ashdod, 7747629, Israel

Soroka Medical Center ( Site 0549)

Beersheba, 8410101, Israel

Rambam Health Care Campus-Oncology Division ( Site 0543)

Haifa, 3109601, Israel

Hadassah Ein Kerem Medical Center ( Site 0546)

Jerusalem, 9112001, Israel

Meir Medical Center ( Site 0544)

Kfar Saba, 4428164, Israel

Rabin Medical Center ( Site 0545)

Petah Tikva, 4941492, Israel

Chaim Sheba Medical Center ( Site 0541)

Ramat Gan, 5262000, Israel

Sourasky Medical Center ( Site 0542)

Tel Aviv, 6423906, Israel

Yitzhak Shamir Medical Center. ( Site 0547)

Ẕerifin, 70300, Israel

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)

Meldola, Emilia-Romagna 47014, Italy

A.O. Universitaria di Modena ( Site 0454)

Modena, Emilia-Romagna 41124, Italy

Istituto Clinico Humanitas Research Hospital ( Site 0452)

Rozzano, Lombardy 20089, Italy

Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)

Pozzuoli, Napoli 80078, Italy

Centro Di Riferimento Oncologico ( Site 0800)

Aviano, Pordenone 33081, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)

Verona, Veneto 37134, Italy

Medical Oncology Ospedale San Donato ( Site 0461)

Arezzo, 52100, Italy

Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)

Bologna, 40138, Italy

Azienda Ospedaliera Cannizzaro ( Site 0458)

Catania, 95126, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)

Naples, 80131, Italy

Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

Roma, 00152, Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)

Roma, 00168, Italy

Azienda Ospedaliera Santa Maria Terni ( Site 0456)

Terni, 05100, Italy

Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)

Udine, 33100, Italy

National Cancer Center Hospital East ( Site 0702)

Kashiwa, Chiba 2778577, Japan

Toho University Sakura Medical Center ( Site 0703)

Sakura, Chiba 285-8741, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0716)

Matsuyama, Ehime 791-0280, Japan

Iizuka Hospital ( Site 0744)

Iizuka, Fukuoka 820-8505, Japan

Hakodate Goryoukaku Hospital ( Site 0739)

Hakodate, Hokkaido 040-8611, Japan

Kanazawa University Hospital ( Site 0701)

Kanazawa, Ishikawa-ken 920-8641, Japan

Kitasato University Hospital ( Site 0705)

Sagamihara, Kanagawa 252-0375, Japan

Yokohama City University Medical Center ( Site 0706)

Yokohama, Kanagawa 232-0024, Japan

Miyagi Cancer Center ( Site 0747)

Natori-shi, Miyagi 981-1293, Japan

Nara Medical University Hospital ( Site 0715)

Kashihara, Nara 634-8522, Japan

Kindai University Hospital ( Site 0714)

Sayama, Osaka 589-8511, Japan

The University of Osaka Hospital ( Site 0713)

Suita, Osaka 565-0871, Japan

Saitama Medical University International Medical Center ( Site 0708)

Hidaka, Saitama 350-1298, Japan

Saitama Medical Center ( Site 0743)

Kawagoe, Saitama 350-8550, Japan

Dokkyo Medical University Saitama Medical Center ( Site 0707)

Koshigaya, Saitama 343-8555, Japan

Hamamatsu University Hospital ( Site 0720)

Hamamatsu, Shizuoka 431-3192, Japan

Yamaguchi University Hospital ( Site 0717)

Ube, Yamaguchi 755-8505, Japan

Chiba Cancer Center ( Site 0704)

Chiba, 260-8717, Japan

Kyushu University Hospital ( Site 0718)

Fukuoka, 812-8582, Japan

Hiroshima Prefectural Hospital ( Site 0748)

Hiroshima, 734-8530, Japan

University of Miyazaki Hospital ( Site 0721)

Miyazaki, 889-1692, Japan

Nagasaki University Hospital ( Site 0719)

Nagasaki, 852-8510, Japan

Toranomon Hospital ( Site 0711)

Tokyo, 105-8470, Japan

Nippon Medical School Hospital ( Site 0709)

Tokyo, 113-8603, Japan

Keio University Hospital ( Site 0710)

Tokyo, 160-8582, Japan

Radboud University Medical Center ( Site 0470)

Nijmegen, Gelderland 6525 GA, Netherlands

Maastricht University Medical Centre ( Site 0467)

Maastricht, Limburg 6229 HX, Netherlands

Amphia Hospital Location Molengracht ( Site 0474)

Breda, North Brabant 4818 CK, Netherlands

Catharina Ziekenhuis ( Site 0472)

Eindhoven, North Brabant 5623 EJ, Netherlands

Noordwest Ziekenhuisgroep NWZ ( Site 0468)

Alkmaar, North Holland 1815 JD, Netherlands

Vrije Universiteit Medisch Centrum ( Site 0479)

Amsterdam, North Holland 1081 HV, Netherlands

Tergooiziekenhuizen ( Site 0466)

Hilversum, North Holland 1213 XZ, Netherlands

Spaarne Ziekenhuis ( Site 0473)

Hoofddorp, North Holland 2134TM, Netherlands

Ziekenhuisgroep Twente ( Site 0469)

Hengelo, Overijssel 7555 DL, Netherlands

Haaglanden MC - locatie Antoniushove ( Site 0471)

Leidschendam, South Holland 2501 ck, Netherlands

Franciscus Gasthuis en Vlietland ( Site 0489)

Schiedam, South Holland 3118 JH, Netherlands

Tauranga Hospital ( Site 0215)

Tauranga, Bay of Plenty 3112, New Zealand

Canterbury Regional Cancer & Blood Service ( Site 0195)

Christchurch, Canterbury 8011, New Zealand

Auckland City Hospital ( Site 0193)

Auckland, 1023, New Zealand

Przychodnia Lekarska Komed ( Site 0628)

Konin, Greater Poland Voivodeship 62-500, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland

Clinical Best Solutions ( Site 0622)

Warsaw, Masovian Voivodeship 02-793, Poland

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)

Koszalin, West Pomeranian Voivodeship 75-581, Poland

Salve Medica SP ( Site 0686)

Lodz, Łódź Voivodeship 91-211, Poland

Provita Prolife Centrum Medyczne ( Site 0630)

Tomaszów Mazowiecki, Łódź Voivodeship 97-200, Poland

Puerto Rico Medical Research Center LLC ( Site 1122)

San Juan, 00918, Puerto Rico

FDI Clinical Research ( Site 1121)

San Juan, 00927, Puerto Rico

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

Chelyabinsk, Chelyabinsk Oblast 454087, Russia

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

Krasnoyarsk, Krasnoyarsk Krai 660133, Russia

State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital" ( Site 0588)

Gatchina, Leningradskaya Oblast' 188300, Russia

Russian Scientific Center of Roentgenoradiology ( Site 0559)

Moscow, Moscow 117485, Russia

Central Clinical Hospital with Polyclinic ( Site 0562)

Moscow, Moscow 121359, Russia

Omsk Clinical Oncology Dispensary ( Site 0568)

Omsk, Omsk Oblast 644013, Russia

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

Samara, Samara Oblast 443031, Russia

Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)

Tomsk, Tomsk Oblast 634050, Russia

National Cancer Center ( Site 0174)

Goyang-si, Kyonggi-do 10408, South Korea

Seoul National University Bundang Hospital ( Site 0175)

Seongnam-si, Kyonggi-do 13620, South Korea

Asan Medical Center ( Site 0176)

Songpagu, Seoul 05505, South Korea

Seoul National University Hospital ( Site 0171)

Seoul, 03080, South Korea

Samsung Medical Center ( Site 0172)

Seoul, 06351, South Korea

Instituto Catalan de Oncologia - ICO ( Site 0330)

L'Hospitalet de Llobregat, Barcelona 08908, Spain

Hospital Parc Tauli ( Site 0335)

Sabadell, Barcelona 08208, Spain

Institut Català d'Oncologia (ICO) - Girona ( Site 0321)

Girona, Gerona 17007, Spain

Instituto Valenciano de Oncologia ( Site 0331)

Valencia, Valenciana, Comunitat 46009, Spain

Hospital del Mar ( Site 0333)

Barcelona, 08003, Spain

Hospital Provincial San Pedro Alcantara ( Site 0326)

Cáceres, 10003, Spain

Hospital Universitario Gregorio Maranon ( Site 0327)

Madrid, 28007, Spain

MD Anderson Cancer Center Madrid ( Site 0332)

Madrid, 28033, Spain

Hospital Clinico San Carlos ( Site 0324)

Madrid, 28040, Spain

Hospital Universitario HM Sanchinarro ( Site 0322)

Madrid, 28050, Spain

Hospital Quiron Madrid ( Site 0325)

Madrid, 28223, Spain

Hospital Universitario Virgen de la Victoria ( Site 0337)

Málaga, 29016, Spain

Hospital Virgen del Rocio ( Site 0329)

Seville, 41013, Spain

National Cheng Kung University Hospital ( Site 0134)

Tainen, Tainan 704, Taiwan

China Medical University Hospital ( Site 0132)

Taichung, 40447, Taiwan

Taichung Veterans General Hospital ( Site 0133)

Taichung, 407, Taiwan

National Taiwan University Hospital ( Site 0131)

Taipei, 10048, Taiwan

Taipei Veterans General Hospital ( Site 0135)

Taipei, 11217, Taiwan

Ege University Medicine of Faculty ( Site 0661)

Bornova, İzmir 35100, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)

Adana, 01250, Turkey (Türkiye)

Ankara University Hospital Cebeci ( Site 0613)

Ankara, 06100, Turkey (Türkiye)

Hacettepe Universitesi-oncology hospital ( Site 0615)

Ankara, 06230, Turkey (Türkiye)

Ankara City Hospital-Medical Oncology ( Site 0616)

Ankara, 06800, Turkey (Türkiye)

T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 0620)

Istanbul, 34440, Turkey (Türkiye)

Acıbadem Maslak Hastanesi ( Site 0660)

Istanbul, 34457, Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)

Istanbul, 34722, Turkey (Türkiye)

Cherkasy Regional Oncology Dispensary ( Site 1203)

Cherkassy, Cherkasy Oblast 18009, Ukraine

Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)

Dnipro, Dnipropetrovsk Oblast 49005, Ukraine

Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)

Dnipropetrovsk, Dnipropetrovsk Oblast 49055, Ukraine

Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76008, Ukraine

Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R ( Site 1209)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine

CNPE Regional Center of Oncology-oncourology department ( Site 1202)

Kharkiv, Kharkiv Oblast 61070, Ukraine

LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific ( Site 1207)

Kiev, Kyivska Oblast 08720, Ukraine

Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)

Kyiv, Kyivska Oblast 03115, Ukraine

University Hospitals Bristol NHS Foundation Trust ( Site 0530)

Bristol, Bristol, City of BS2 8ED, United Kingdom

Cambridge University Hospitals NHS Trust ( Site 0540)

Cambridge, Cambridgeshire CB2 0QQ, United Kingdom

Torbay Hospital ( Site 0532)

Torquay, Devon TQ2 7AA, United Kingdom

University College London Hospitals NHS Foundation Trust ( Site 0482)

London, London, City of NW1 2PG, United Kingdom

Western General Hospital ( Site 0531)

Edinburgh, Midlothian EH4 2XU, United Kingdom

Royal Marsden Hospital (Sutton) ( Site 0526)

London, Surrey SM3 5PT, United Kingdom

Musgrove Park Hospital ( Site 0537)

Taunton, Worcestershire TA1 5DA, United Kingdom

Mount Vernon Cancer Centre ( Site 0536)

Northwood, HA6 2RN, United Kingdom