Clinical Trial Details

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 Aarhus University Hospital (Aarhus, Denmark)
Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands)
Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare (Boulogne-Billancourt, France)
Assistance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard (Paris, France)
Assistance Publique - Hopitaux de Paris - Hopital Saint-Louis (Paris, France)
Azienda Ospedaliera Di Padova - University di Padova (Padova, Italy)
Blumenthal Cancer Center (Charlotte, United States of America)
Box Hill Hospital (Box Hill, Australia)
CHRU de Lille (Lille, France)
CHU de Lyon - Hopital Lyon Sud (Pierre-Benite (Lyon), France)
Cabrini Hospital (Malvern, Australia)
California Pacific Medical Center (San Francisco, United States of America)
City Clinical Oncology Dispensary (Saint-Petersburg, Russian Federation)
Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America)
David Maddison Clinical Sciences (Newcastle, Australia)
Erasmus MC (Rotterdam, Netherlands)
Federal State Treasury Educational Institution of High Professional Education «Medical Military Academy n.a. S.M.Kirov» of Ministry of Defense of Russian Federation (Saint-Petersburg, Russian Federation)
Fred Hutchison Seattle Cancer Care Alliance (Seattle, United States of America)
General Teaching Hospital In Prague (Prague 2, Czech Republic)
Gustave Roussy (Villejuif, 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, France)
Hospital Clinic Universitari 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, 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, Sweden)
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, 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 Hospital NHS Trust (London, United Kingdom)
State Healthcare Institution (Izhevsk, 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 uniklinieken (Vienna, Austria)
Universitaetsklinikum Wuerzburg (Wuerzburg, Germany)
Universitaetsmedizin Goettingen - Georg-August Universitaet (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 New Mexico, Cancer Care Alliance (Albuquerque, United States of America)
Vanderbilt Ingram Cancer Center - Breast Center (Nashville, United States of America)
Westmead Hospital (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