A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)


Condition: Renal Cell Carcinoma

Intervention:

  • Biological: Pembrolizumab
  • Drug: Placebo (saline solution)

Purpose: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03142334

Sponsor: Merck Sharp & Dohme Corp.

Primary Outcome Measures:

  • Measure: Disease-free Survival (DFS) as Assessed by the Investigator
  • Time Frame: Up to approximately 72 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: Up to approximately 72 months
  • Safety Issue:
  • Measure: Adverse Events (AEs)
  • Time Frame: Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
  • Safety Issue:
  • Measure: Study Treatment Discontinuations Due to an AE
  • Time Frame: Up to approximately 12 months
  • Safety Issue:
  • Measure: First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
  • Time Frame: Up to approximately 72 months
  • Safety Issue:
  • Measure: First Local Recurrence with Visceral Lesion or Distant Metastasis with Visceral Lesion or Secondary Systemic Malignancy with Visceral Lesion (DRSS2) as Assessed by the Investigator
  • Time Frame: Up to approximately 72 months
  • Safety Issue:
  • Measure: DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
  • Time Frame: Up to approximately 72 months
  • Safety Issue:
  • Measure: OS According to Participant PD-L1 Expression Status (Positive, Negative)
  • Time Frame: Up to approximately 72 months
  • Safety Issue:
  • Measure: Plasma Clearance (CL) of Pembrolizumab
  • Time Frame: Cycles 1 and 2: Pre-dose and 0.5 hours (h) after end of infusion; Cycles 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months)
  • Safety Issue:
  • Measure: Volume of Distribution (VD) of Pembrolizumab
  • Time Frame: Cycles 1 and 2: Pre-dose and 0.5 h after end of infusion; Cycles 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months)
  • Safety Issue:
  • Measure: Development of Anti-pembrolizumab Antibodies
  • Time Frame: Cycles 1, 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months)
  • Safety Issue:
  • Measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
  • Time Frame: Baseline and Cycles 1, 5, 9, 13, and 17, treatment discontinuation, 30 day follow up, and annually during post-treatment follow up. Each cycle is 3 weeks long. (Up to approximately 72 months)
  • Safety Issue:
  • Measure: Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
  • Time Frame: Baseline and Cycles 1, 5, 9, 13, and 17, treatment discontinuation, 30 day follow up, and annually during post-treatment follow up. Each cycle is 3 weeks long. (Up to approximately 72 months)
  • Safety Issue:

Estimated Enrollment: 950

Study Start Date: June 9, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment.
  • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment.
  • Has intermediate-high risk, high risk, or M1 NED RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0 2. High risk RCC: pT4, Any Grade N0, M0; pT, Any stage, Any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤1 year from nephrectomy (metachronous).
  • Has received no prior systemic therapy for advanced RCC.
  • Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins.
  • Must have undergone a nephrectomy and/or metastasectomy ≥28 days prior to signing informed consent and ≤12 weeks prior to randomization.
  • Must be tumor-free as assessed by the Investigator and validated by either computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and chest, abdomen, and pelvis and a bone scan ≤28 days from randomization.
  • Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available).
  • Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
  • Has adequate organ function.

Exclusion Criteria:

  • Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization.
  • Has received prior radiotherapy for RCC.
  • Has pre-existing brain or bone metastatic lesions.
  • Has residual thrombus post nephrectomy in the vena renalis or vena cava.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed.
  • Has a known additional malignancy that is progressing or required active treatment ≤3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history of, or is currently on, dialysis.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has known active hepatitis B or hepatitis C virus infection.
  • Has a known history of active tuberculosis (Bacillus tuberculosis).
  • Has had a prior solid organ transplant.
  • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
  • Is pregnant or breastfeeding, or 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 received prior therapy with an anti-programmed cell death protein 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 co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
  • Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (i.e., must be ≤ Grade 1 or at Baseline) from AEs due to previously administered agents.
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • 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.

Contact:

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

Locations:

  • Arizona Oncology Associates, PC- HAL ( Site 8018)
  • Phoenix Arizona 85016 United States
  • USC Norris Comprehensive Cancer Center ( Site 0038)
  • Los Angeles California 90033 United States
  • Sansum Clinic Research ( Site 8014)
  • Santa Barbara California 93105 United States
  • Stanford Cancer Center ( Site 0028)
  • Stanford California 94305 United States
  • Rocky Mountain Cancer Center ( Site 8010)
  • Aurora Colorado 80012 United States
  • Georgetown University Medical Center ( Site 0002)
  • Washington District of Columbia 20007 United States
  • Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
  • Boca Raton Florida 33486 United States
  • Manatee Medical Research Institute ( Site 0039)
  • Bradenton Florida 34205 United States
  • Woodlands Medical Specialists, PA ( Site 8021)
  • Pensacola Florida 32503 United States
  • Northwest Georgia Oncology Centers PC ( Site 0014)
  • Marietta Georgia 30060 United States
  • Illinois Cancer Specialists ( Site 8001)
  • Niles Illinois 60714 United States
  • McFarland Clinic ( Site 0025)
  • Ames Iowa 50010-3014 United States
  • University of Iowa Hospital and Clinics ( Site 0031)
  • Iowa City Iowa 52242 United States
  • University Medical Center New Orleans ( Site 0053)
  • New Orleans Louisiana 70112 United States
  • Weinberg Cancer Institute at Franklin Square ( Site 0046)
  • Baltimore Maryland 21237 United States
  • Maryland Oncology Hematology, P.A. ( Site 8020)
  • Rockville Maryland 20850 United States
  • Beth Israel Deaconess Medical Ctr. ( Site 0044)
  • Boston Massachusetts 02215 United States
  • Dana-Farber Cancer Institute (Boston) ( Site 0007)
  • Boston Massachusetts 02215 United States
  • University of Michigan ( Site 0045)
  • Ann Arbor Michigan 48109 United States
  • Karmanos Cancer Institute ( Site 0013)
  • Detroit Michigan 48201 United States
  • Henry Ford Hospital ( Site 0032)
  • Detroit Michigan 48202 United States
  • Quest Research Institute ( Site 0036)
  • Royal Oak Michigan 48073 United States
  • Fairview Southdale Medical Oncology Clinic ( Site 0041)
  • Edina Minnesota 55435 United States
  • Minnesota Oncology Specialist, PA ( Site 8002)
  • Minneapolis Minnesota 55404 United States
  • Park Nicollet Frauenshuh Cancer Center ( Site 0020)
  • Saint Louis Park Minnesota 55426 United States
  • St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
  • Billings Montana 59102 United States
  • Nebraska Cancer Specialists ( Site 0012)
  • Omaha Nebraska 68130 United States
  • Comprehensive Cancer Centers of Nevada ( Site 8013)
  • Las Vegas Nevada 89148 United States
  • Rutgers Cancer Institute of New Jersey ( Site 0059)
  • New Brunswick New Jersey 08903 United States
  • University of New Mexico Cancer Center ( Site 0043)
  • Albuquerque New Mexico 87106 United States
  • Montefiore Medical Center ( Site 0009)
  • Bronx New York 10461 United States
  • Duke University ( Site 0037)
  • Durham North Carolina 27710 United States
  • Oncology Hematology Care, Inc. ( Site 8008)
  • Cincinnati Ohio 45242 United States
  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
  • Tulsa Oklahoma 74146 United States
  • Northwest Cancer Specialists, P.C. ( Site 8006)
  • Tigard Oregon 97223 United States
  • St. Luke's University Health Network ( Site 0042)
  • Easton Pennsylvania 18045 United States
  • Abramson Cancer Center ( Site 0010)
  • Philadelphia Pennsylvania 19104 United States
  • Charleston Hematology Oncology Associates PA ( Site 8000)
  • Charleston South Carolina 29414 United States
  • Medical University of South Carolina ( Site 0033)
  • Charleston South Carolina 29425 United States
  • Avera Cancer Institute ( Site 0023)
  • Sioux Falls South Dakota 57105 United States
  • Urology Associates [Nashville, TN] ( Site 0063)
  • Nashville Tennessee 37209 United States
  • Texas Oncology-Austin Central ( Site 8003)
  • Austin Texas 78731 United States
  • Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
  • Dallas Texas 75246 United States
  • UT Southwestern Medical Center ( Site 0003)
  • Dallas Texas 75390 United States
  • Texas Oncology-Denton South ( Site 8016)
  • Denton Texas 76210 United States
  • Texas Oncology-Memorial City ( Site 8015)
  • Houston Texas 77024 United States
  • UTHealth/Memorial Hermann Cancer Center ( Site 0001)
  • Houston Texas 77030 United States
  • Texas Oncology- Paris ( Site 8004)
  • Paris Texas 75460-5004 United States
  • CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
  • San Antonio Texas 78229 United States
  • Texas Oncology-Tyler ( Site 8005)
  • Tyler Texas 75702 United States
  • Texas Oncology-Waco ( Site 8012)
  • Waco Texas 76712 United States
  • IHO Corporation- Utah Cancer Specialists ( Site 0055)
  • Salt Lake City Utah 84106 United States
  • Virginia Oncology Associates ( Site 8011)
  • Norfolk Virginia 23502 United States
  • Providence Regional Cancer Partnership ( Site 0016)
  • Everett Washington 98201 United States
  • SCCA/UW ( Site 0029)
  • Seattle Washington 98109 United States
  • Cancer Care Northwest ( Site 0021)
  • Spokane Washington 99202 United States
  • Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
  • Spokane Washington 99208 United States
  • Northwest Medical Specialties, PLLC ( Site 0034)
  • Tacoma Washington 98405 United States
  • Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
  • Yakima Washington 98902 United States
  • University of Wisconsin Carbone Cancer Center ( Site 0019)
  • Madison Wisconsin 53792 United States
  • Sanatorio Parque ( Site 1104)
  • Rosario Santa Fe S2000DSV Argentina
  • Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
  • Buenos Aires C1012AAR Argentina
  • Fundacion Favaloro ( Site 1110)
  • Buenos Aires C1093AAS Argentina
  • Instituto Medico Alexander Fleming ( Site 1105)
  • Buenos Aires C1426ANZ Argentina
  • Centro Oncologico Riojano Integral ( Site 1101)
  • La Rioja F5300COE Argentina
  • Centro Oncologico de Integracion Regional. COIR ( Site 1109)
  • Mendoza M5500AYB Argentina
  • Sanatorio Britanico ( Site 1106)
  • Rosario S2000CVB Argentina
  • Instituto de Oncologia de Rosario ( Site 1100)
  • Rosario S2000KZE Argentina
  • Centro Medico San Roque ( Site 1108)
  • Tucuman T4000IAK Argentina
  • Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
  • Viedma R8500ACE Argentina
  • Saint George Hospital [Kogarah, Australia] ( Site 0707)
  • Kogarah New South Wales 2217 Australia
  • Macquarie University Hospital ( Site 0700)
  • Macquarie Park New South Wales 2109 Australia
  • Adelaide Cancer Centre ( Site 0703)
  • Kurralta Park South Australia 5037 Australia
  • Bendigo Cancer Centre ( Site 0704)
  • Bendigo Victoria 3550 Australia
  • Box Hill Hospital ( Site 0701)
  • Box Hill Victoria 3128 Australia
  • Ballarat Health Services ( Site 0705)
  • Ballarat 3350 Australia
  • Fiona Stanley Hospital ( Site 0702)
  • Perth 6150 Australia
  • Liga Norte Riograndense Contra o Cancer ( Site 1013)
  • Natal Rio Grande Do Norte 59075-740 Brazil
  • Universidade de Caxias do Sul ( Site 1004)
  • Caxias do Sul Rio Grande Do Sul 95070-560 Brazil
  • Hospital Bruno Born ( Site 1015)
  • Lajeado RS 95900-000 Brazil
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
  • Porto Alegre RS 90610-000 Brazil
  • Hospital Nossa Senhora da Conceicao ( Site 1000)
  • Porto Alegre RS 91350-200 Brazil
  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
  • Barretos Sao Paulo 14784-400 Brazil
  • Fundacao Dr Amaral Carvalho ( Site 1005)
  • Jau Sao Paulo 17210-120 Brazil
  • Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
  • Sao Paulo SP 01246-000 Brazil
  • Casa de Saude Santa Marcelina ( Site 1006)
  • Sao Paulo SP 08270-120 Brazil
  • Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
  • Curitiba 80510-130 Brazil
  • Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
  • Ribeirao Preto 14048-900 Brazil
  • COT Centro Oncologico do Triangulo Ltda ( Site 1014)
  • Uberlandia 38408-150 Brazil
  • CancerCare Manitoba ( Site 0119)
  • Winnipeg Manitoba R3E 0V9 Canada
  • Dr. Leon Richard Oncology Centre ( Site 0106)
  • Moncton New Brunswick E1C 8X3 Canada
  • William Osler Health System ( Site 0115)
  • Brampton Ontario L6R 3J7 Canada
  • Juravinski Cancer Centre ( Site 0117)
  • Hamilton Ontario L8V 5C2 Canada
  • London Regional Cancer Program - London HSC ( Site 0107)
  • London Ontario N6A 4L6 Canada
  • Lakeridge Health ( Site 0108)
  • Oshawa Ontario L1G 2B9 Canada
  • Niagara Health System - St. Catharines ( Site 0120)
  • St. Catharines Ontario L2S 0A9 Canada
  • CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
  • Chicoutimi Quebec G7H 5H6 Canada
  • CISSS-CA Hotel Dieu de Levis ( Site 0111)
  • Lévis Quebec G6V 3Z1 Canada
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
  • Montreal Quebec H1T 2M4 Canada
  • St-Jerome Medical Research Inc ( Site 0103)
  • St-Jerome Quebec J7Z 5T3 Canada
  • Allan Blair Cancer Centre ( Site 0116)
  • Regina Saskatchewan S4T 7T1 Canada
  • Saskatoon Cancer Centre ( Site 0105)
  • Saskatoon Saskatchewan S7N 4H4 Canada
  • Instituto Nacional del Cancer ( Site 0912)
  • Santiago Region Metropolitana 8380455 Chile
  • Centro Oncologico Antofagasta ( Site 0914)
  • Antofagasta 1240000 Chile
  • Hospital Regional de La Serena ( Site 0907)
  • La Serena 1710216 Chile
  • Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
  • Rancagua 2820000 Chile
  • Health and Care Chile ( Site 0901)
  • Santiago 7500006 Chile
  • Fundacion Arturo Lopez Perez FALP ( Site 0902)
  • Santiago 7500921 Chile
  • Iram Cancer Research ( Site 0909)
  • Santiago 7630372 Chile
  • Hospital Militar de Santiago ( Site 0911)
  • Santiago 7850000 Chile
  • Pontificia Universidad Catolica de Chile ( Site 0904)
  • Santiago 8330032 Chile
  • Hospital Clinico Universidad de Chile ( Site 0905)
  • Santiago 8380456 Chile
  • Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
  • Temuco 4810469 Chile
  • Oncocentro ( Site 0900)
  • Vina del Mar 2520598 Chile
  • Hospital Pablo Tobon Uribe. ( Site 0805)
  • Medellin Antioquia 050034 Colombia
  • Clinica de la Costa Ltda. ( Site 0804)
  • Barranquilla Atlantico 080020 Colombia
  • Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
  • Valledupar Cesar 200001 Colombia
  • Instituto Nacional de Cancerologia E.S.E ( Site 0807)
  • Bogota Cundinamarca 111161 Colombia
  • Oncologos del Occidente S.A. ( Site 0800)
  • Pereira Risaralda 661002 Colombia
  • Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
  • Bogota 110131 Colombia
  • Oncomedica S.A. ( Site 0801)
  • Monteria 230002 Colombia
  • FN Brno. ( Site 1501)
  • Brno 625 00 Czechia
  • Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
  • Novy Jicin 741 01 Czechia
  • Fakultni nemocnice Olomouc ( Site 1502)
  • Olomouc 775 20 Czechia
  • Fakultni nemocnice Ostrava ( Site 1507)
  • Ostrava 708 52 Czechia
  • Thomayerova nemocnice ( Site 1505)
  • Praha 4 140 59 Czechia
  • Fakultni nemocnice v Motole ( Site 1504)
  • Praha 5 150 06 Czechia
  • Nemocnice Na Bulovce ( Site 1503)
  • Praha 8 180 81 Czechia
  • HYKS ( Site 2300)
  • Helsinki 00290 Finland
  • Keski-Suomen keskussairaala ( Site 2303)
  • Jyvaskyla 40620 Finland
  • Oulun yliopistollinen sairaala - OYS ( Site 2304)
  • Oulu 90220 Finland
  • TAYS ( Site 2301)
  • Tampere 33520 Finland
  • TYKS ( Site 2302)
  • Turku 20521 Finland
  • ICO Centre Paul Papin ( Site 2208)
  • Angers 49055 France
  • CHU Besancon - Hopital Jean Minjoz ( Site 2200)
  • Besancon 25030 France
  • Hopital Saint Andre ( Site 2202)
  • Bordeaux 33000 France
  • Hopital La Timone ( Site 2204)
  • Marseille 13005 France
  • CHU Saint-Eloi ( Site 2203)
  • Montpellier 34295 France
  • Centre Antoine Lacassagne ( Site 2211)
  • Nice 06189 France
  • Hopital Europeen Georges Pompidou ( Site 2206)
  • Paris 75908 France
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
  • Pierre Benite 69310 France
  • Centre Eugene Marquis ( Site 2209)
  • Rennes 35042 France
  • Centre Rene Gauducheau ICO ( Site 2207)
  • Saint Herblain 44805 France
  • Institut Claudius Regaud IUCT Oncopole ( Site 2201)
  • Toulouse 31059 France
  • Campus Charite Mitte ( Site 2120)
  • Berlin 10117 Germany
  • Helios Klinikum Berlin Buch ( Site 2125)
  • Berlin 13125 Germany
  • Universitaetsklinikum Bonn ( Site 2110)
  • Bonn 53127 Germany
  • Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
  • Dresden 01307 Germany
  • Universitatsklinikum Dusseldorf ( Site 2108)
  • Dusseldorf 40225 Germany
  • Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
  • Erlangen 91058 Germany
  • Universitaetsklinikum Essen ( Site 2116)
  • Essen 45122 Germany
  • Universitaetsklinikum Frankfurt ( Site 2121)
  • Frankfurt 60590 Germany
  • Universitaetsklinikum Freiburg ( Site 2119)
  • Freiburg 79106 Germany
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
  • Hamburg 20246 Germany
  • Universitaetsklinikum Jena. ( Site 2104)
  • Jena 07747 Germany
  • Universitaetsklinikum Schleswig Holstein ( Site 2109)
  • Luebeck 23538 Germany
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
  • Mainz 55131 Germany
  • Studienpraxis Urologie ( Site 2115)
  • Nuertingen 72622 Germany
  • Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
  • Trier 54292 Germany
  • Universitaetsklinikum Tuebingen ( Site 2100)
  • Tuebingen 72076 Germany
  • Beaumont Hospital ( Site 1611)
  • Dublin D04 Y8V0 Ireland
  • St Vincents University Hospital ( Site 1610)
  • Dublin D04 Y8V0 Ireland
  • University Hospital Waterford ( Site 1614)
  • Waterford X91 ER8E Ireland
  • Ospedale San Luigi Gonzaga ( Site 2010)
  • Orbassano Torino 10043 Italy
  • Medical Oncology Ospedale San Donato ( Site 2004)
  • Arezzo 52100 Italy
  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
  • Meldola 47014 Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
  • Milano 20133 Italy
  • Istituto Europeo di Oncologia ( Site 2000)
  • Milano 20141 Italy
  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
  • Modena 41125 Italy
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
  • Napoli 80131 Italy
  • Istituto Nazionale Tumori Regina Elena ( Site 2009)
  • Roma 00144 Italy
  • Nagoya University Hospital ( Site 0431)
  • Nagoya Aichi 466-8560 Japan
  • Sapporo Medical University Hospital ( Site 0424)
  • Sapporo Hokkaido 060-8543 Japan
  • Kagawa University Hospital ( Site 0419)
  • Kita-gun Kagawa 761-0793 Japan
  • Japan Community Health care Organization Sendai Hospital ( Site 0430)
  • Sendai Miyagi 981-8501 Japan
  • Nara Medical University Hospital ( Site 0416)
  • Kashihara Nara 634-8522 Japan
  • Kindai University Hospital ( Site 0411)
  • Osakasayama Osaka 589-8511 Japan
  • Osaka Rosai Hospital ( Site 0418)
  • Sakai Osaka 591-8025 Japan
  • Saitama Medical University International Medical Center ( Site 0404)
  • Hidaka Saitama 350-1298 Japan
  • Yamaguchi University Hospital ( Site 0406)
  • Ube Yamaguchi 755-8505 Japan
  • Akita University Hospital ( Site 0433)
  • Akita 010-8543 Japan
  • Harasanshin Hospital ( Site 0402)
  • Fukuoka 812-0033 Japan
  • Kyushu University Hospital ( Site 0413)
  • Fukuoka 812-8582 Japan
  • Kumamoto University Hospital ( Site 0434)
  • Kumamoto 860-8556 Japan
  • Nagano Municipal Hospital ( Site 0429)
  • Nagano 381-8551 Japan
  • Niigata University Medical & Dental Hospital ( Site 0421)
  • Niigata 951-8520 Japan
  • Osaka International Cancer Institute ( Site 0401)
  • Osaka 541-8567 Japan
  • Osaka City University Hospital ( Site 0428)
  • Osaka 545-8586 Japan
  • Toranomon Hospital ( Site 0426)
  • Tokyo 105-8470 Japan
  • Nippon Medical School Hospital ( Site 0400)
  • Tokyo 113-8603 Japan
  • Keio University Hospital ( Site 0407)
  • Tokyo 160-8582 Japan
  • Toyama University Hospital ( Site 0432)
  • Toyama 930-0194 Japan
  • National Cancer Center ( Site 0304)
  • Goyang-si Gyeonggi-do 10408 Korea, Republic of
  • Seoul National University Hospital ( Site 0302)
  • Seoul 03080 Korea, Republic of
  • Severance Hospital Yonsei University Health System ( Site 0303)
  • Seoul 03722 Korea, Republic of
  • Asan Medical Center ( Site 0300)
  • Seoul 05505 Korea, Republic of
  • Samsung Medical Center ( Site 0301)
  • Seoul 06351 Korea, Republic of
  • Amphia Ziekenhuis Breda ( Site 1901)
  • Breda 4819 EV Netherlands
  • Mazowiecki Szpital Onkologiczny ( Site 1316)
  • Wieliszew Mazowieckie 05-135 Poland
  • Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
  • Koscierzyna Pomorskie 83-400 Poland
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
  • Brzozow 36-200 Poland
  • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
  • Bytom 41-902 Poland
  • Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
  • Gdansk 80-219 Poland
  • Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
  • Gdynia 81-519 Poland
  • Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
  • Gliwice 44-101 Poland
  • Przychodnia Lekarska Komed ( Site 1306)
  • Konin 62-500 Poland
  • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
  • Krakow 31-115 Poland
  • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
  • Lublin 20-090 Poland
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
  • Otwock 05-400 Poland
  • Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
  • Poznan 60-569 Poland
  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
  • Torun 87-100 Poland
  • Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
  • Warszawa 02-793 Poland
  • Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
  • Warszawa 04-141 Poland
  • Ivanovo Regional Oncology Dispensary ( Site 1204)
  • Ivanovo 153040 Russian Federation
  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
  • Krasnoyarsk 660133 Russian Federation
  • N.N. Blokhin NMRCO ( Site 1206)
  • Moscow 115478 Russian Federation
  • Russian Scientific Center of Roentgenoradiology ( Site 1201)
  • Moscow 117997 Russian Federation
  • National Medical Research Radiology Centre ( Site 1200)
  • Moscow 125284 Russian Federation
  • Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
  • Murmansk 183057 Russian Federation
  • Omsk Clinical Oncology Dispensary ( Site 1209)
  • Omsk 644013 Russian Federation
  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
  • Saint Petersburg 197758 Russian Federation
  • Tomsk Scientific Research Institute of Oncology ( Site 1208)
  • Tomsk 634028 Russian Federation
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
  • Ufa 450054 Russian Federation
  • Clinical Hospital Bashkirsky Medical State University ( Site 1202)
  • Ufa 450083 Russian Federation
  • Hospital Universitario Infanta Cristina ( Site 1805)
  • Badajoz 06080 Spain
  • Hospital de la Santa Creu i Sant Pau ( Site 1807)
  • Barcelona 08026 Spain
  • Hospital de Girona Dr. Josep Trueta ( Site 1806)
  • Girona 17007 Spain
  • Hospital Universitario Gregorio Maranon ( Site 1801)
  • Madrid 28007 Spain
  • Hospital Universitario Ramon y Cajal ( Site 1800)
  • Madrid 28034 Spain
  • Hospital Universitario Virgen de la Victoria ( Site 1808)
  • Malaga 29010 Spain
  • Clinica Universitaria de Navarra ( Site 1803)
  • Pamplona 31008 Spain
  • Instituto Valenciano de Oncologia ( Site 1804)
  • Valencia 46009 Spain
  • Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
  • Valencia 46026 Spain
  • China Medical University Hospital ( Site 0200)
  • Taichung 40447 Taiwan
  • Taichung Veterans General Hospital ( Site 0204)
  • Taichung 407 Taiwan
  • National Taiwan University Hospital ( Site 0202)
  • Taipei 10002 Taiwan
  • Taipei Veterans General Hospital ( Site 0201)
  • Taipei 112 Taiwan
  • Chang Gung Medical Foundation. Linkou ( Site 0203)
  • Taoyuan 333 Taiwan
  • North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
  • Stoke-On-Trent Staffordshire ST4 6QG United Kingdom
  • Western General Hospital ( Site 1600)
  • Edinburgh EH4 2XU United Kingdom
  • The Beatson West of Scotland Cancer Centre ( Site 1605)
  • Glasgow G12 0YN United Kingdom
  • Royal Free Hospital ( Site 1609)
  • London NW3 2QG United Kingdom
  • St George s Healthcare Trust ( Site 1608)
  • London SW17 0QT United Kingdom
  • Charing Cross Hospital ( Site 1607)
  • London W6 8RF United Kingdom
  • The Christie NHS Foundation Trust ( Site 1602)
  • Manchester M20 4BX United Kingdom
  • The James Cook University Hospital ( Site 1606)
  • Middlesbrough TS4 3BW United Kingdom

View trial on ClinicalTrials.gov


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