A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)


Condition: Prostatic Neoplasms

Intervention:

  • Biological: Pembrolizumab
  • Drug: Enzalutamide
  • Drug: Placebo

Purpose: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03834493

Sponsor: Merck Sharp & Dohme Corp.

Primary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
  • Time Frame: Up to approximately 52 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Prostate-specific Antigen (PSA) Response Rate
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Prostate-specific Antigen (PSA) Undetectable Rate
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Time to Prostate-specific Antigen (PSA) Progression
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Time to First Symptomatic Skeletal-related Event (SSRE)
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Number of Participants Who Experience an Adverse Event (AE)
  • Time Frame: Up to approximately 52 months
  • Safety Issue:
  • Measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
  • Time Frame: Up to approximately 52 months
  • Safety Issue:

Estimated Enrollment: 1200

Study Start Date: July 28, 2019

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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)
  • Is abiraterone-naive or are intolerant to/progressed on abiraterone
  • 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 ≥120 days after the last dose of study treatment: Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
  • Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
  • 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 (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or 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, or darolutamide
  • 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 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 120 days after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant

Contact:

  • Toll Free Number
  • 1-888-577-8839

Locations:

  • University of South Alabama, Mitchell Cancer Institute ( Site 0065)
  • Mobile Alabama 36604 United States
  • St. Joseph Heritage Healthcare ( Site 0069)
  • Fullerton California 92835 United States
  • UCLA Department of Medicine - Hematology & Oncology ( Site 0081)
  • Santa Monica 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 Medical Center ( 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
  • Nebraska Cancer Specialists ( Site 0034)
  • Omaha Nebraska 68130 United States
  • Comprehensive Cancer Centers of Nevada ( Site 0092)
  • Las Vegas Nevada 89169 United States
  • 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
  • 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 Sciences 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
  • Instituto de Investigaciones Clinicas ( Site 1000)
  • Mar del Plata Buenos Aires B7600FZN Argentina
  • Centro de Diagnostico Urologico ( Site 1008)
  • Buenos Aires Caba C1120AAT Argentina
  • Sanatorio Parque ( Site 1002)
  • Rosario Santa Fe S2000DSV Argentina
  • Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
  • Buenos Aires C1012AAR Argentina
  • Hospital Aleman ( Site 1004)
  • Buenos Aires C1118AAT Argentina
  • Instituto Medico Alexander Fleming ( Site 1010)
  • Buenos Aires C1426ANZ Argentina
  • CEMAIC ( Site 1014)
  • Cordoba X5008HHW Argentina
  • Instituto de Oncologia de Rosario ( Site 1015)
  • Rosario S2000KZE 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 Foundation ( Site 0149)
  • Greenslopes Queensland 4120 Australia
  • Gold Coast University Hospital ( Site 0150)
  • Southport Queensland 4125 Australia
  • Royal Adelaide Hospital ( Site 0154)
  • Adelaide South Australia 5000 Australia
  • Monash Health-Monash Medical Centre ( Site 0147)
  • Clayton Victoria 3168 Australia
  • Fiona Stanley Hospital ( Site 0162)
  • Murdoch Western Australia 6150 Australia
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
  • Linz 4020 Austria
  • Medizinische Universitaet Wien ( Site 0375)
  • Wien 1090 Austria
  • Hospital de Caridade de Ijui ( Site 1038)
  • Ijui RS 98700-000 Brazil
  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
  • Itajai Santa Catarina 88301-215 Brazil
  • Hospital de Base de Sao Jose do Rio Preto. ( Site 1022)
  • Sao Jose do Rio Preto Sao Paulo 15090-000 Brazil
  • A.C. Camargo Cancer Center ( Site 1026)
  • Sao Paulo SP 01509-900 Brazil
  • 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
  • Princess Margaret Cancer Centre ( Site 0107)
  • Toronto Ontario M5G 2M9 Canada
  • CISSS de la Monteregie-Centre ( Site 0119)
  • Greenfield Park Quebec J4V 2H1 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
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103)
  • Quebec G1R 2J6 Canada
  • Fundacion Arturo Lopez Perez ( Site 1049)
  • Santiago 7500921 Chile
  • Pontificia Universidad Catolica de Chile ( Site 1047)
  • Santiago 8330024 Chile
  • Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
  • Santiago 8420383 Chile
  • Private practice ( Site 1048)
  • Temuco 4810148 Chile
  • Sociedad de Investigaciones Medicas Limitadas ( Site 1041)
  • Temuco 4810469 Chile
  • Oncocentro ( Site 1045)
  • Vina del Mar 2520598 Chile
  • Hospital Pablo Tobon Uribe ( Site 1066)
  • Medellin Antioquia 050034 Colombia
  • Centro Medico Imbanaco de Cali S.A ( Site 1064)
  • Cali Valle Del Cauca 760042 Colombia
  • Hemato Oncologos S.A. ( Site 1065)
  • Cali Valle 760046 Colombia
  • Biomelab S A S ( Site 1067)
  • Barranquilla 080002 Colombia
  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
  • Bogota 110311 Colombia
  • Oncomedica S.A. ( Site 1057)
  • Monteria 230002 Colombia
  • Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1068)
  • Valledupar 200002 Colombia
  • CHU Amiens Picardie Site Sud Amiens ( Site 0438)
  • Amiens 80000 France
  • Institut Sainte Catherine ( Site 0447)
  • Avignon 84000 France
  • CHU Jean Minjoz ( Site 0423)
  • Besancon 25000 France
  • Institut Bergonie ( Site 0421)
  • Bordeaux 33076 France
  • CHU de Brest -Site Hopital Morvan ( Site 0441)
  • Brest 29200 France
  • Centre Jean Perrin ( Site 0434)
  • Clermont-Ferrand 63011 France
  • Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
  • Montpellier 34298 France
  • Centre D Oncologie de Gentilly ( Site 0432)
  • Nancy 54100 France
  • Centre Hospitalier Regional du Orleans ( Site 0430)
  • Orleans 45100 France
  • C.H.U. Lyon Sud ( Site 0436)
  • Pierre Benite 69310 France
  • C.H. de Saint Quentin ( Site 0481)
  • Saint Quentin 02321 France
  • Hopital Foch ( Site 0428)
  • Suresnes 92150 France
  • Institut Claudius Regaud IUCT Oncopole ( Site 0418)
  • Toulouse 31059 France
  • Institut Gustave Roussy ( Site 0416)
  • Villejuif 94800 France
  • Beaumont Hospital ( Site 0726)
  • Dublin D09 V2N0 Ireland
  • Tallaght University Hospital ( Site 0730)
  • Dublin D24 NROA Ireland
  • Mid Western Cancer Centre ( Site 0728)
  • Limerick V94 F858 Ireland
  • Rambam Medical Center ( 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)
  • Petach-Tikwa 4941492 Israel
  • Chaim Sheba Medical Center ( Site 0541)
  • Ramat Gan 5266202 Israel
  • Sourasky Medical Center ( Site 0542)
  • Tel Aviv 6423906 Israel
  • Assaf Harofe Medical Center Nephrology division ( Site 0547)
  • Zerifin 7030001 Israel
  • Istituto Clinico Humanitas Research Hospital ( Site 0452)
  • Rozzano Milano 20089 Italy
  • Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)
  • Bologna 40138 Italy
  • Azienda Ospedaliera Cannizzaro ( Site 0458)
  • Catania 95126 Italy
  • A.O. Universitaria di Modena ( Site 0454)
  • Modena 41100 Italy
  • Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
  • Roma 00152 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 277-8577 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
  • Kanazawa University Hospital ( Site 0701)
  • Kanazawa Ishikawa 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
  • Nara Medical University Hospital ( Site 0715)
  • Kashihara Nara 634-8522 Japan
  • Kindai University Hospital ( Site 0714)
  • Osakasayama Osaka 589-8511 Japan
  • Osaka University Hospital ( Site 0713)
  • Suita Osaka 565-0871 Japan
  • Saitama Medical University International Medical Center ( Site 0708)
  • Hidaka Saitama 350-1298 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
  • University of Miyazaki Hospital ( Site 0721)
  • Miyazaki 889-1692 Japan
  • Nagasaki University Hospital ( Site 0719)
  • Nagasaki 852-8501 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
  • National Cancer Center ( Site 0174)
  • Goyang-si Gyeonggi-do 10408 Korea, Republic of
  • Seoul National University Bundang Hospital ( Site 0175)
  • Seongnam-si Gyeonggi-do 10408 Korea, Republic of
  • Seoul National University Hospital ( Site 0171)
  • Seoul 03080 Korea, Republic of
  • Asan Medical Center ( Site 0176)
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center ( Site 0172)
  • Seoul 06351 Korea, Republic of
  • Tergooiziekenhuizen ( Site 0466)
  • Hilversum Noord-holland 1213 XZ Netherlands
  • Franciscus Gasthuis en Vlietland ( Site 0489)
  • Rotterdam Zuid-Holland 3118 JH Netherlands
  • Noordwest Ziekenhuisgroep NWZ ( Site 0468)
  • Alkmaar 1815 JD Netherlands
  • Ziekenhuisgroep Twente ( Site 0469)
  • Almelo 7609 PP Netherlands
  • Vrije Universiteit Medisch Centrum ( Site 0479)
  • Amsterdam 1081 HV Netherlands
  • Amphia Hospital Location Molengracht ( Site 0474)
  • Breda 4818 CK Netherlands
  • Catharina Ziekenhuis ( Site 0472)
  • Eindhoven 5623 EJ Netherlands
  • Spaarne Ziekenhuis ( Site 0473)
  • Hoofddorp 2134 TM Netherlands
  • Medisch Centrum Haaglanden ( Site 0471)
  • Leidschendam 2262 BA Netherlands
  • Maastricht University Medical Centre ( Site 0467)
  • Maastricht 6229 HX Netherlands
  • Radboud University Medical Center ( Site 0470)
  • Nijmegen 6525 GA Netherlands
  • Auckland City Hospital ( Site 0193)
  • Auckland 1023 New Zealand
  • Canterbury Regional Cancer & Blood Service ( Site 0195)
  • Christchurch 8011 New Zealand
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)
  • Bydgoszcz 85-796 Poland
  • Przychodnia Lekarska Komed ( Site 0628)
  • Konin 62-500 Poland
  • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)
  • Koszalin 75-581 Poland
  • Provita Prolife Centrum Medyczne ( Site 0630)
  • Tomaszow Mazowiecki 97-200 Poland
  • Clinical Best Solutions ( Site 0622)
  • Warszawa 02-793 Poland
  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
  • Chelyabinsk 454087 Russian Federation
  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
  • Krasnoyarsk 644013 Russian Federation
  • Russian Scientific Center of Roentgenoradiology ( Site 0559)
  • Moscow 117997 Russian Federation
  • Central Clinical Hospital with Polyclinic ( Site 0562)
  • Moscow 121359 Russian Federation
  • Omsk Clinical Oncology Dispensary ( Site 0568)
  • Omsk 644013 Russian Federation
  • SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
  • Saint Petersburg 191104 Russian Federation
  • Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
  • Saint Petersburg 197758 Russian Federation
  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
  • Saint Petersburg 197758 Russian Federation
  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
  • Samara 443031 Russian Federation
  • Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
  • Tomsk 634050 Russian Federation
  • Instituto Catalan de Oncologia - ICO ( Site 0330)
  • L Hospitalet De Llobregat Barcelona 08908 Spain
  • Hospital Quiron Madrid ( Site 0325)
  • Pozuelo de Alarcon Madrid 28223 Spain
  • Hospital del Mar ( Site 0333)
  • Barcelona 08003 Spain
  • Hospital Provincial San Pedro Alcantara ( Site 0326)
  • Caceres 10003 Spain
  • Hospital Josep Trueta ( Site 0321)
  • Girona 17007 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 Universitario Virgen de la Victoria ( Site 0337)
  • Malaga 29010 Spain
  • Hospital Parc Tauli ( Site 0335)
  • Sabadell 08208 Spain
  • Hospital Virgen del Rocio ( Site 0329)
  • Sevilla 41013 Spain
  • Instituto Valenciano de Oncologia ( Site 0331)
  • Valencia 46009 Spain
  • China Medical University Hospital ( Site 0132)
  • Taichung 40447 Taiwan
  • Taichung Veterans General Hospital ( Site 0133)
  • Taichung 407 Taiwan
  • National Cheng Kung University Hospital ( Site 0134)
  • Tainen 704 Taiwan
  • National Taiwan University Hospital ( Site 0131)
  • Taipei 10048 Taiwan
  • Taipei Veterans General Hospital ( Site 0135)
  • Taipei 11217 Taiwan
  • Torbay Hospital ( Site 0532)
  • Torquay Devon TQ2 7AA United Kingdom
  • University Hospitals Bristol NHS Foundation Trust ( Site 0530)
  • Bristol BS2 8ED United Kingdom
  • Cambridge University Hospitals NHS Trust ( Site 0540)
  • Cambridge CB2 0QQ United Kingdom
  • University College London Hospitals NHS Foundation Trust ( Site 0482)
  • London NW1 2PG United Kingdom
  • Royal Marsden Hospital ( Site 0526)
  • Sutton SM2 5PT United Kingdom
  • Musgrove Park Hospital ( Site 0537)
  • Taunton TA1 5DA United Kingdom

View trial on ClinicalTrials.gov