Closed to Patient Entry

Date of activation: 27-Jul-2015
Date Step1 close: 07-Oct-2016
Date Step2 close: 19-Jun-2017

Yes

Phase 3
Randomized blind

EORTC Groups: 900 - All Groups: 900

Drug
Pembrolizumab, Blind trial medication-1325

• Alexander Eggermont (Study Coordinator), Prinses Maxima Centrum voor Kinderoncologie, Utrecht
• Caroline Robert (Study Coordinator), Gustave Roussy, VILLEJUIF CEDEX
• Katrien Baus (Clinical Operations Assistant), EORTC Headquarters, Brussels
• Jose Casas (TR Scientist), EORTC Headquarters, Brussels
• Nathalie Elaut (Data Manager), EORTC Headquarters, Brussels
• Hazal Erkol (Data Manager), EORTC Headquarters, Brussels
• Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
• Sven Janssen (Data Manager), EORTC Headquarters, Brussels
• Nitish Jha (Statistical Analyst), EORTC Headquarters, Brussels
• Michal Kicinski (Statistician), EORTC Headquarters, Brussels
• Robby Louis (Data Manager), EORTC Headquarters, Brussels
• Belma Malanda (Project Manager), EORTC Headquarters, Brussels
• Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
• Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
• Bette Stofs (Pharmacovigilance Manager), EORTC Headquarters, Brussels
• Leen Wijnen (Data Manager), EORTC Headquarters, Brussels
• Gaetan de Schaetzen (Senior Clinical Operations Manager), EORTC Headquarters, Brussels

• Melanoma

• EORTC Melanoma Group

• APHP - Univ Paris Saclay - Hopital Ambroise Pare (Boulogne Billancourt, France)
• APHP Centre - Univ de Paris Cite - Hopital Cochin (PARIS, France)
• APHP Nord - Univ De Paris Cite - Hop. Bichat- Claude Bernard (Paris, France)
• APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
• Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
• Alfred Hospital (Prahran, Australia)
• Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
• Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy)
• Azienda Ospedaliera Di Padova - University di Padova (Padova, Italy)
• Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy)
• CHRU de Besancon - Hopital Saint-Jacques (BESANCON CEDEX, France)
• CHRU de Lille (LILLE CEDEX, France)
• CHU Amiens Picardie - Site Sud (Amiens, France)
• CHU Montpellier-Hopital St. Eloi (MONTPELLIER CEDEX 5, France)
• CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (BORDEAUX CEDEX, France)
• CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
• CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France)
• CHU de Nice - Hopital De L'Archet (NICE, France)
• CHU de Tours - Hopital Trousseau (Chambray Les tours, France)
• California Pacific Medical Center (San Francisco, United States of America)
• Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom)
• Centre Eugene Marquis (RENNES CEDEX, France)
• Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame (Montreal, Canada)
• Centre Leon Berard (Lyon, France)
• Christchurch Hospital - Canterbury regional Cancer and Haematology service (Christchurch , New Zealand)
• Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom)
• Cliniques Universitaires Saint-Luc (Brussels, Belgium)
• David Maddison Clinical Sciences (Newcastle, Australia)
• East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
• Eastern Health - Box Hill Hospital (Box Hill, Australia)
• Elbe Kliniken - Buxtehude (Buxtehude, Germany)
• Emory University (Atlanta, United States of America)
• Federal State Budgetary Institution, Russian oncology scientific centre named after N.N. Blokhin RAMS (Moscow, Russian Federation)
• Greater Poland Cancer Centre (Poznan, Poland)
• Gustave Roussy (VILLEJUIF CEDEX, France)
• Hadassah University Hospital- Ein Kerem (Jerusalem, Israel)
• Hautklinik Linden Der Medizinischen Hochschule Hannover (Hannover, Germany)
• Helse Bergen HF -Haukeland Hospital - Univ. Hosp (Bergen, Norway)
• Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland)
• Herlev Hospital - University Copenhagen (Herlev, Denmark)
• Hopital de La Timone (APHM) (MARSEILLE, France)
• Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
• Hospital Clinic de Barcelona (Barcelona, Spain)
• Hospital Universitario 12 De Octubre (Madrid, Spain)
• ICON Cancer Center -Gold Coast University Hospital (Southport QLD, Australia)
• IRCCS - Fondazione G. Pascale (Napoli, Italy)
• IRCCS-Regina Elena National Cancer Center (Roma, Italy)
• Institut Jules Bordet (Anderlecht, Belgium)
• Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France)
• Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
• Instituto Portugues de Oncologia do Porto Francisco Gentil (Porto, Portugal)
• Istituto Europeo di Oncologia (Milano, Italy)
• Istituto Nazionale Per La Ricerca Sul Cancro (Genova, Italy)
• Kantonsspital St Gallen (St Gallen, Switzerland)
• Kumamoto University Hospital (Chuo-ku Kumamoto, Japan)
• Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom)
• Leiden University Medical Centre (Leiden, Netherlands)
• Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Dermatologie und Allergologie - Innenstadt (Muenchen, Germany)
• Lutheran General Hospital / Advocate Cancer Care Center (Park Ridge, United States of America)
• Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
• Medical University of Graz (Graz, Austria)
• Melanoma Institute Australia -The Poche center (Wollstonecraft, Australia)
• Mid and South Essex NHS - Broomfield Hospital (Broomfield Chelmsford Essex, United Kingdom)
• Military Medical Academy (Belgrade, Serbia)
• Municipal Oncology Hospital 62 (Moscow, Russian Federation)
• NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
• NHS Tayside - Ninewells Hospital (Dundee, Scotland, United Kingdom)
• Nagoya University Hospital (Nagoya, Japan)
• National Cancer Center - Hospital Tokyo (Tokyo, Japan)
• North Shore Hospital - Waitemata DHB (Takapuna, New Zealand)
• Odense University Hospital (Odense C, Denmark)
• Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
• Peter Maccallum Cancer Institute (Melbourne, Australia)
• Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
• Rabin Medical Center - Tel Aviv (Petah Tikva, Israel)
• Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
• Rambam Health Care Campus, Oncology Institute (Haifa, Israel)
• Royal Adelaide Hospital (Adelaide, Australia)
• Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
• Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom)
• Royal Perth Hospital (Perth, Australia)
• Sahlgrenska Universitetssjukhuset (Goteborg, Sweden)
• Sheba Medical Center Tel Hashomer (Ramat Gan, Israel)
• Siteman Cancer Center (St Louis, United States of America)
• Tampere University Hospital (Tampere, Finland)
• The Christie NHS Foundation Trust (Manchester, United Kingdom)
• The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
• The Ottawa Hospital - General Campus (Ottawa, Canada)
• U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
• UCSF University of California San Francisco Medical Center-Mount Zion (San Francisco, United States of America)
• UMC-Academisch Ziekenhuis Utrecht (Utrecht, Netherlands)
• Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy)
• UniversitaetsSpital Zurich (Zurich, Switzerland)
• Universitaetsklinikum - Essen (Essen, Germany)
• Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany)
• Universitaetsklinikum Freiburg (Freiburg, Germany)
• Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany)
• Universitaetsklinikum Leipzig - Clinic for Dermatology, Venerology and Allergology (Leipzig, Germany)
• Universitaetsklinikum Schleswig-Holstein - Campus Kiel-Klinik Dermatologie, Venerologie und Allergologie (Kiel, Germany)
• Universitaetsklinikum Tuebingen - Hautklinik (Tuebingen, Germany)
• Universitaetsklinikum Wien - AKH unikliniken (Vienna, Austria)
• Universitaetsmedizin Goettingen - INVALID Dermatology (Goettingen, Germany)
• Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany)
• University Medical Center Groningen (Groningen, Netherlands)
• University Of Iowa Hospital And Clinics (Iowa City, United States of America)
• University of Alberta - Cross Cancer Institute (Edmonton, Canada)
• Waikato Hospital (Hamilton, New Zealand)
• Wellington Hospital (Wellington, New Zealand)
• Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia)
• Yamanashi University Hospital (Chuo-Shi, Japan)

http://clinicaltrials.gov/study/NCT02362594

NCT02362594

2014-004944-37