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Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma Group

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 27-Jul-2015
Date Step1 close: 07-Oct-2016
Date Step2 close: 19-Jun-2017
Data management at EORTC Yes
Design Phase 3
Randomized blind
Targeted Sample size EORTC Groups: 900 - All Groups: 900
Treatment Drug
Pembrolizumab, Blind trial medication-1325
Study Staff Alexander Eggermont (Study Coordinator) , Prinses Maxima Centrum voor Kinderoncologie, Utrecht
Caroline Robert (Study Coordinator) , Gustave Roussy, Villejuif
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
Catherine Fortpied (Unblinded statistician) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Sven Janssen (Data Manager) , EORTC Headquarters, Brussels
Nitish Jha (Statistician) , EORTC Headquarters, Brussels
Michal Kicinski (Statistician) , EORTC Headquarters, Brussels
Robby Louis (Data Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Larissa Polders (Data Manager) , EORTC Headquarters, Brussels
Miguel Remis (Data Manager) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Marie-Sophie Robert (Project Manager) , EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Stefan Suciu (Statistician) , EORTC Headquarters, Brussels
Leen Wijnen (Data Manager) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Melanoma
Participating groups EORTC Melanoma Group
Recruiting centers Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Alfred Hospital (Prahran, Australia)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare (Boulogne-Billancourt, France)
Assistance Publique - Hopitaux de Paris - Hopital Avicenne (Bobigny, France)
Assistance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard (Paris, France)
Assistance Publique - Hopitaux de Paris - Hopital Cochin (Paris, France)
Assistance Publique - Hopitaux de Paris - Hopital Saint-Louis (Paris, France)
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)
Box Hill Hospital (Box Hill, Australia)
CHRU de Besancon - Hopital Saint-Jacques (Besancon, France)
CHRU de Lille (Lille, France)
CHU Amiens - Hopital Sud (Salouel, France)
CHU Montpellier-Hopital St. Eloi (Montpellier, France)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (Bordeaux, France)
CHU de Grenoble - La Tronche - Hopital A. Michallon (Grenoble, France)
CHU de Lyon - Hopital Lyon Sud (Pierre-Benite (Lyon), France)
CHU de Nice - Hopital De L'Archet (Nice, France)
CHU de Reims - Hopital Robert Debre (Reims, France)
CHU de Tours - Hopital Trousseau (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, France)
Centre Hospitalier De Pau (Pau, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame (Montreal, Canada)
Centre Leon Berard (Lyon, France)
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
Chris O'Brien Lifehouse (Camperdown NSW , Australia)
Christchurch Hospital (Christchurch, New Zealand)
Clatterbridge NHS -Wirral (Wirral, United Kingdom)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
David Maddison Clinical Sciences (Newcastle, Australia)
Dunedin Hospital (Dunedin, New Zealand)
East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
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)
Gold Coast University Hospital (Southport QLD, Australia)
Gustave Roussy (Villejuif, France)
Hadassah University Hospital (Jerusalem, Israel)
Haukeland Hospital - University Of Bergen (Bergen, Norway)
Hautklinik Linden Der Medizinischen Hochschule Hannover (Hannover, Germany)
Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Hopital de La Timone (APHM) (Marseille, France)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital Distrital De Santarem (Santarem, Portugal)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
IRCCS - Fondazione G. Pascale (Napoli, Italy)
IRCCS-Regina Elena National Cancer Center (Roma, Italy)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut de Cancerologie de Lorraine (Vandoeuvre-Les-Nancy, France)
Institute Of Oncology & Radiology (Belgrade, Serbia)
Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
Instituto Portugues de Oncologia do Porto (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 (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)
Mt Sinai Comprehensive Cancer Center (Miami Beach, United States of America)
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-shi, Japan)
National Cancer Center Hospital (Tokyo, Japan)
Niigata Prefectural Cancer Center Hospital (Niigata-City, Japan)
North Shore Hospital - Waitemata DHB (Takapuna, New Zealand)
Odense University Hospital (Odense, Denmark)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Peter Maccallum Cancer Institute (East Melbourne VIC, 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)
Republic Clinical Oncology Dispensary of Ministry of Health of Tatarstan Republic (Kazan, Russian Federation)
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 (Ramat Gan, Israel)
Shizuoka Cancer Center (Sunto-gun, Japan)
Siteman Cancer Center (St Louis, United States of America)
Soroka Medical Center (Beer Sheva, Israel)
St George's Hospital NHS Trust (London, United Kingdom)
Tampere University Hospital (Tampere, Finland)
Technische Universitaet Muenchen (Muenchen, Germany)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Great Poland Cancer Centre (Poznan, Poland)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
The Ottawa Hospital - General Campus (Ottawa, Canada)
Tom Baker Cancer Centre (Calgary, 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)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsklinikum - Essen (Essen, Germany)
Universitaetsklinikum Carl Gustav Carus (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 Schleswig-Holstein - Campus Luebeck (Luebeck, Germany)
Universitaetsklinikum Tuebingen - Hautklinik (Tuebingen, Germany)
Universitaetsklinikum Tuebingen - Hautklinik (Tuebingen, Germany)
Universitaetsklinikum Wien - AKH uniklinieken (Vienna, Austria)
Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany)
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany)
University Medical Center - Bezanijska Kosa (Belgrade, Serbia)
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)
Protocol summary
NCT number NCT02362594
EudraCT 2014-004944-37
Financial Support Fully supported