EORTC-18071-MG

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Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) 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 Publications

Trial Status	LT-FU ongoing
Dates	Date of activation: 06-May-2008 Date Step1 close: 20-Jul-2011 Date Step2 close: 30-Aug-2011
Data management at EORTC	Yes
Design	Phase 3 Randomized blind
Targeted Sample size	All Groups: 950
Treatment	Drug Ipilimumab
Study Staff	Alexander Eggermont (Study Coordinator) , Prinses Maxima Centrum voor Kinderoncologie, Utrecht Katrien Baus (Clinical Operations Assistant) , EORTC Headquarters, Brussels Sven Janssen (Data Manager) , EORTC Headquarters, Brussels Stefan Suciu (Statistician) , 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 Nord - Univ De Paris Cite - Hop. Bichat- Claude Bernard (Paris, France) APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France) Aarhus University Hospital (Aarhus, Denmark) Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands) Azienda Ospedaliera Di Padova - University di Padova (Padova, Italy) Blumenthal Cancer Center (Charlotte, United States of America) CHRU de Lille (LILLE CEDEX, France) CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France) Cabrini Hospital (Malvern, Australia) California Pacific Medical Center (San Francisco, United States of America) Cancer Research Center (Moscow, Russian Federation) Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America) David Maddison Clinical Sciences (Newcastle, Australia) Eastern Health - Box Hill Hospital (Box Hill, Australia) Erasmus MC (Rotterdam, Netherlands) Fred Hutchison Seattle Cancer Care Alliance (Seattle, United States of America) General Teaching Hospital In Prague (Prague 2, Czech Republic) Gustave Roussy (VILLEJUIF CEDEX, France) H. Lee Moffitt Cancer Center Research Institute (Tampa, United States of America) Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hopitaux Sud - Hopital Sainte-Marguerite (APHM) (MARSEILLE CEDEX 09, France) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) IRCCS - Fondazione G. Pascale (Napoli, Italy) IRCCS-Regina Elena National Cancer Center (Roma, Italy) Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France) Istituto Nazionale Per La Ricerca Sul Cancro (Genova, Italy) Itinerary Clinical Hospital on Saratov-2 Station of RZD LLC (Saratov, Russian Federation) Ivanovo Regional Oncology Dispensary (Ivanovo, Russian Federation) Karolinska University Hospital, location Solna (Stockholm Solna, Sweden) Kirov Medical Military Academy (Saint-Petersburg, Russian Federation) Krasnoyarsk Regional Clinical Oncology Dispensary (Krasnoyarsk, Russian Federation) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Leiden University Medical Centre (Leiden, Netherlands) Lipetsk Regional Oncology Dispensary (Lipetsk, Russian Federation) Lutheran General Hospital / Advocate Cancer Care Center (Park Ridge, United States of America) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Masaryk Memorial Cancer Institute (Brno, Czech Republic) Massachussets General Hospital Cancer Center (Boston, United States of America) Melanoma Center Atlantic Health Center (Morristown, United States of America) Memorial Sloan-Kettering Cancer Center - Memorial hospital (New York, United States of America) Mid and South Essex NHS - Broomfield Hospital (Broomfield Chelmsford Essex, United Kingdom) Northern California Melanoma Center (San Francisco, United States of America) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Odense University Hospital (Odense C, Denmark) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) Regional Clinical Oncology Dispensary (Krasnodar, Russian Federation) Regional Oncology Dispensary of Minzdrav of Karelia Republic (Petrozavodsk, Russian Federation) Republic Clinical Oncology Dispensary of Ministry of Health of Bashkortostan Republic (Ufa, Russian Federation) Republic Clinical Oncology Dispensary of Ministry of Health of Tatarstan Republic (Kazan, Russian Federation) Siteman Cancer Center (St Louis, United States of America) St George's University Hospital NHS Trust Foundation (London, United Kingdom) State Healthcare Institution (Izhevsk, Russian Federation) State Healthcare Institution of Saint Petersburg - Outpatient policlinic (Saint-Petersburg, Russian Federation) Stavropol Clinical Oncology Center - Pyatigorsk (Pyatigorsk, Russian Federation) The Angeles Clinic and Research Institute (Los Angeles, United States of America) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) Tom Baker Cancer Centre (Calgary, Canada) Tomsk Regional Oncology Dispensary (Tomsk, Russian Federation) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) UniversitaetsMedizin Mannheim (Mannheim, Germany) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany) Universitaetsklinikum Koeln (Koeln, 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 Wien - AKH unikliniken (Vienna, Austria) Universitaetsklinikum Wuerzburg (Wuerzburg, Germany) Universitaetsmedizin Goettingen - INVALID Dermatology (Goettingen, Germany) Universitair Ziekenhuis Gent (Gent, Belgium) University Hospital Southampton NHS Foundation Trust - Southampton General Hospital (Southampton, United Kingdom) University Of Utah - Huntsman Cancer Institute (Salt Lake City, United States of America) University Of Utah - Huntsman Cancer Institute (Salt Lake City, United States of America) University of Alberta - Cross Cancer Institute (Edmonton, Canada) University of New Mexico, Cancer Care Alliance (Albuquerque, United States of America) Vanderbilt Ingram Cancer Center - Breast Center (Nashville, United States of America) Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia) Yale University School Of Medicine (New Haven, United States of America)
Centers to be activated	Medical University of Graz - Dermatology (Graz, Austria) Moscow Regional Oncology Dispensary of Minzdrav of Moscow region (Balashikha, Russian Federation) Tver Regional Clinical Oncology Dispensary (Tver, Russian Federation) University Of Arkansas For Medical Sciences (Little Rock, United States of America)
Protocol summary	http://clinicaltrials.gov/ct/show/
NCT number
EudraCT	2007-001974-10
Financial Support	Fully supported