A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)


Condition: Prostatic Neoplasms

Intervention:

  • Biological: Pembrolizumab
  • Drug: Olaparib
  • Drug: Abiraterone acetate
  • Drug: Prednisone
  • Drug: Enzalutamide

Purpose: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03834519

Sponsor: Merck Sharp & Dohme Corp.

Primary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: Up to approximately 29 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 29 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
  • Time Frame: Up to approximately 29 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 29 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 29 months
  • Safety Issue:
  • Measure: Time to Prostate-Specific Antigen (PSA) Progression
  • Time Frame: Up to approximately 29 months
  • Safety Issue:
  • Measure: Time to First Symptomatic Skeletal-Related Event (SSRE)
  • Time Frame: Up to approximately 29 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 29 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 29 months
  • Safety Issue:
  • Measure: Number of Participants Who Experience an Adverse Event (AE)
  • Time Frame: Up to approximately 29 months
  • Safety Issue:
  • Measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
  • Time Frame: Up to approximately 29 months
  • Safety Issue:

Estimated Enrollment: 780

Study Start Date: May 2, 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 receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
  • Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI)
  • Has received prior treatment with abiraterone acetate OR enzalutamide, but not both
  • Have disease that progressed during or after treatment with abiraterone acetate for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression)
  • Participants that received abiraterone acetate for mHSPC may not have received abiraterone acetate or enzalutamide for mCRPC
  • Have received docetaxel chemotherapy regimen for mCRPC and have had progressive disease during or after treatment with docetaxel
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
  • If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, must have been receiving stable doses prior to randomization
  • Must agree to refrain from donating sperm during the intervention period and for at least 180 days thereafter PLUS Be abstinent from heterosexual intercourse OR Agree to use contraception unless confirmed to be azoospermic AND Also agree to use a male condom when engaging in any activity that allows passage of ejaculate to another person of any sex
  • Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated. Samples from tumors progressing at 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 the past 2 years
  • Has a history of (noninfectious) pneumonitis requiring steroids, or has current pneumonitis
  • Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g., hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA [qualitative] is detected)
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • 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 myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has (≥Grade 3) hypersensitivity to pembrolizumab and/or any of its excipients
  • Has known hypersensitivity to the components or excipients in olaparib, abiraterone acetate, prednisone or prednisolone, or enzalutamide
  • Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
  • Has received an anticancer monoclonal antibody (mAb) prior to randomization
  • Has received prior treatment with olaparib or any other PARP inhibitor
  • Has received prior treatment with apalutamide or darolutamide
  • Has received prior treatment with enzalutamide or apalutamide for metastatic hormone-sensitive prostate cancer
  • Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA (e.g., saw palmetto) prior to the date of randomization
  • Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
  • Has received prior treatment with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137)
  • Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP] (CYP3A4) that cannot be discontinued for the duration of the study
  • Has received a previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT) or a solid organ transplant
  • Has received a live vaccine within 30 days prior to the date of 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 date of randomization
  • Has a bone "superscan"
  • Is expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention

Contact:

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

Locations:

  • St. Joseph Heritage Healthcare ( Site 0069)
  • Fullerton California 92835 United States
  • UCLA Hematology & Oncology ( Site 0081)
  • Santa Monica California 90404 United States
  • Georgia Cancer Center at Augusta University ( Site 0026)
  • Augusta Georgia 30912 United States
  • Quincy Medical Group ( Site 0021)
  • Quincy Illinois 62301 United States
  • Tulane Cancer Center ( Site 0066)
  • New Orleans Louisiana 70112 United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)
  • Baltimore Maryland 21287 United States
  • Chesapeake Urology Research Associates ( Site 0076)
  • Towson Maryland 21204 United States
  • Beth Israel Deaconess Medical Ctr. ( Site 0093)
  • Boston Massachusetts 02215 United States
  • Dana Farber Cancer Institute ( Site 0033)
  • Boston Massachusetts 02215 United States
  • UMass Memorial Medical Center ( Site 0053)
  • Worcester Massachusetts 01655 United States
  • Barbara Ann Karmanos Cancer Institute ( Site 0077)
  • Detroit Michigan 48201 United States
  • Henry Ford Health System ( Site 0039)
  • Detroit Michigan 48202 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 89109 United States
  • University of New Mexico Cancer Center ( Site 0048)
  • Albuquerque New Mexico 87131 United States
  • Memorial Medical Center ( Site 0095)
  • Las Cruces New Mexico 88011 United States
  • Associated Medical Professionals of NY ( Site 0060)
  • Syracuse New York 13210 United States
  • Duke Cancer Center Cary ( Site 0010)
  • Cary North Carolina 27511 United States
  • The Urology Group- Cincinnati ( Site 0094)
  • Cincinnati Ohio 45212 United States
  • University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)
  • Cleveland Ohio 44106 United States
  • Carolina Urologic Research Center ( Site 0070)
  • Myrtle Beach South Carolina 29572 United States
  • Huntsman Cancer Institute ( Site 0002)
  • Salt Lake City Utah 84112 United States
  • Virginia Cancer Institute ( Site 0052)
  • Richmond Virginia 23230 United States
  • Blue Ridge Cancer Care ( Site 0086)
  • Roanoke Virginia 24014 United States
  • Froedtert and 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
  • Centro de Diagnostico Urologico ( Site 1008)
  • Buenos Aires Caba C1120AAT Argentina
  • Sanatorio Parque ( Site 1002)
  • Rosario Santa Fe S2000DSV Argentina
  • Hospital Aleman ( Site 1004)
  • Buenos Aires C1118AAT Argentina
  • Instituto Medico Alexander Fleming ( Site 1010)
  • Buenos Aires C1426ANZ Argentina
  • Hospital Britanico de Buenos Aires ( Site 1006)
  • Caba C1280AEB Argentina
  • CEMAIC ( Site 1014)
  • Cordoba X5008HHW Argentina
  • St. Vincent's Hospital ( Site 0158)
  • Darlinghurst New South Wales 2010 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
  • Southern Medical Day Care Centre ( Site 0160)
  • Wollongong New South Wales 2500 Australia
  • Royal Brisbane and Women s Hospital ( Site 0155)
  • Herston Queensland 4029 Australia
  • John Flynn Hospital & Medical Centre ( Site 0164)
  • Tugun Queensland 4224 Australia
  • Box Hill Hospital ( Site 0146)
  • Box Hill Victoria 3128 Australia
  • Peter MacCallum Cancer Centre ( Site 0152)
  • Melbourne Victoria 3000 Australia
  • Fiona Stanley Hospital ( Site 0162)
  • Murdoch Western Australia 6150 Australia
  • Medizinische Universitat Graz ( Site 0374)
  • Graz 8036 Austria
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
  • Linz 4020 Austria
  • SCRI-CCCIT GesmbH ( Site 0371)
  • Salzburg 5020 Austria
  • Medizinische Universitaet Wien ( Site 0375)
  • Wien 1090 Austria
  • Hospital de Caridade de Ijui ( Site 1038)
  • Ijui RS 98700-000 Brazil
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
  • Porto Alegre RS 90610-000 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
  • Cross Cancer Institute ( Site 0110)
  • Edmonton Alberta T6G 1Z2 Canada
  • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)
  • Kelowna British Columbia V1Y 5L3 Canada
  • BC Cancer-Vancouver Center ( Site 0112)
  • Vancouver British Columbia V5Z 4E6 Canada
  • Nova Scotia Health Authority QEII-HSC ( Site 0114)
  • Halifax Nova Scotia B3H 2Y9 Canada
  • Juravinski Cancer Centre ( Site 0116)
  • Hamilton Ontario L8V 5C2 Canada
  • Princess Margaret Cancer Centre ( Site 0107)
  • Toronto Ontario M5G 2M9 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
  • 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
  • Centre Leon Berard ( Site 0422)
  • Lyon 69008 France
  • Institut Paoli Calmettes ( Site 0419)
  • Marseille 13009 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
  • Institut Mutualiste Montsouris ( Site 0446)
  • Paris 75014 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
  • Charite Universitaetsmedizin Berlin ( Site 0301)
  • Berlin 10117 Germany
  • Universitaetsklinikum Duesseldorf ( Site 0306)
  • Duesseldorf 40225 Germany
  • Universitaetsklinikum Erlangen ( Site 0303)
  • Erlangen 91054 Germany
  • Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
  • Freiburg 79106 Germany
  • Klinikum Rechts der Isar ( Site 0300)
  • Muenchen 81675 Germany
  • Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
  • Nuernberg 90419 Germany
  • Studienpraxis Urologie ( Site 0309)
  • Nuertingen 72622 Germany
  • Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
  • Trier 54292 Germany
  • Universitaetsklinik fuer Urologie ( Site 0307)
  • Tuebingen 72076 Germany
  • Tallaght University Hospital ( Site 0730)
  • Dublin D24 NROA Ireland
  • Mid Western Cancer Centre ( Site 0728)
  • Limerick V94 F858 Ireland
  • Assaf Harofe ( Site 0547)
  • Be'er- Ya'akov 7030001 Israel
  • 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
  • Istituto Clinico Humanitas Research Hospital ( Site 0452)
  • Rozzano Milano 20089 Italy
  • Medical Oncology Ospedale San Donato ( Site 0461)
  • Arezzo 52100 Italy
  • Policlinico S.Orsola-Malpighi ( Site 0453)
  • Bologna 40138 Italy
  • Azienda Ospedaliera Cannizzaro ( Site 0458)
  • Catania 95126 Italy
  • Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
  • Roma 00152 Italy
  • Azienda Ospedaliera Santa Maria Terni ( Site 0456)
  • Terni 05100 Italy
  • Presidio Ospedaliero Santa Chiara ( Site 0451)
  • Trento 38122 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
  • Chonnam National University Hwasun Hospital ( Site 0174)
  • Hwasun Gun Jeollanam Do 58128 Korea, Republic of
  • National Cancer Center ( Site 0176)
  • Goyang-si 10408 Korea, Republic of
  • Severance Hospital Yonsei University Health System ( Site 0173)
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center ( Site 0171)
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center ( Site 0172)
  • Seoul 06351 Korea, Republic of
  • Franciscus Gasthuis en Vlietland ( Site 0489)
  • Rotterdam Zuid-Holland 3118 JH Netherlands
  • Ziekenhuisgroep Twente ( Site 0469)
  • Almelo 7609 PP Netherlands
  • Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
  • Amsterdam 1066 CX Netherlands
  • Vrije Universiteit Medisch Centrum ( Site 0479)
  • Amsterdam 1081 HV Netherlands
  • Spaarne Ziekenhuis ( Site 0473)
  • Hoofddorp 2134 TM Netherlands
  • Medisch Centrum Leeuwarden ( Site 0477)
  • Leeuwarden 8934 AD Netherlands
  • Medisch Centrum Haaglanden ( Site 0471)
  • Leidschendam 2262 BA Netherlands
  • Radboud University Medical Center ( Site 0470)
  • Nijmegen 6525 GA Netherlands
  • Erasmus MC ( Site 0475)
  • Rotterdam 3015 GD Netherlands
  • Auckland City Hospital ( Site 0193)
  • Auckland 1023 New Zealand
  • 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 634028 Russian Federation
  • Instituto Catalan de Oncologia - ICO ( Site 0330)
  • L Hospitalet De Llobregat Barcelona 08908 Spain
  • Hospital San Pedro de Alcantara ( Site 0326)
  • Caceres Extremadura 10003 Spain
  • Hospital Quiron Madrid ( Site 0325)
  • Pozuelo de Alarcon Madrid 28223 Spain
  • Hospital del Mar ( Site 0333)
  • Barcelona 08003 Spain
  • Hospital General Universitari Vall d Hebron ( Site 0334)
  • Barcelona 08035 Spain
  • Hospital Clinic ( Site 0323)
  • Barcelona 08036 Spain
  • Hospital Josep Trueta ( Site 0321)
  • Girona 17007 Spain
  • Hospital Universitario Virgen de la Victoria ( Site 0337)
  • Malaga 29010 Spain
  • Hospital Parc Tauli ( Site 0335)
  • Sabadell 08208 Spain
  • China Medical University Hospital ( Site 0132)
  • Taichung 404 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
  • Cambridge University Hospitals NHS Trust ( Site 0540)
  • Cambridge Cambridgeshire CB2 0QQ United Kingdom
  • University Hospitals Bristol NHS Foundation Trust ( Site 0530)
  • Bristol BS2 8ED United Kingdom
  • Royal Marsden Hospital ( Site 0526)
  • Sutton SM2 5PT United Kingdom

View trial on ClinicalTrials.gov