Study

EORTC-18071-MG

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.

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
  • 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 Magnolia Campus (Tampa (FL), 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 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

NCT number

EudraCT