EORTC-1325-MG

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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 CEDEX Katrien Baus (Clinical Operations Assistant) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Terry Desmae (TR Manager) , 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
Type of cancer	Melanoma
Participating groups	EORTC Melanoma Group
Recruiting centers	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) Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany) 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) 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) 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 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)
Protocol summary	http://clinicaltrials.gov/study/NCT02362594
NCT number	NCT02362594
EudraCT	2014-004944-37
Financial Support	Fully supported