EORTC protocol 18071

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 StatusOpen
DatesDate of activation: 06/05/2008
Data management at EORTCFull
Phase3
Randomized trialYes
TypeAdjuvant
Targeted Sample sizeEORTC Groups: - - All Groups: 950
Number of steps2
DrugIPILIMUMAB
Study StaffAlexander Eggermont (Study Coordinator) - Erasmus University Medical Center, Rotterdam
Stefan Suciu (Statistician) - EORTC, Brussels
Isabelle Blangenois (Data Manager) - EORTC, Brussels
Sven Janssen (Data Manager) - EORTC, Brussels
Niels Lema (Data Manager) - EORTC, Brussels
Larissa Polders (Data Manager) - EORTC, Brussels
Simon Vanderschaeghe (Data Manager) - EORTC, Brussels
Jocelyne Flament (Coordinating Physician) - EORTC, Brussels
Gaetan de Schaetzen (Project Manager) - EORTC, Brussels, gaetan.deschaetzen( at )eortc.be, +32 2 7741618
Type of cancerMelanoma
Participating GroupsEORTC Melanoma Group(Coordinating Group)
BMS 18071
Currently authorized centers Westmead Hospital (Westmead, Australia) - Inst. 1052
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia) - Inst. 1060
Sir Charles Gairdner Hospital (Nedlands, Australia) - Inst. 1064
Box Hill Hospital (Box Hill, Australia) - Inst. 1072
Greenslopes Private Hospital (Greenslopes, Australia) - Inst. 1078
David Maddison Clinical Sciences (Newcastle, Australia) - Inst. 1094
Cabrini Hospital (Malvern, Australia) - Inst. 9199
Medical University Vienna - General Hospital (Vienna, Austria) - Inst. 906
Medical University of Graz (Graz, Austria) - Inst. 908
Universiteit Gent (Gent, Belgium) - Inst. 104
U.Z. Gasthuisberg (Leuven, Belgium) - Inst. 147
Tom Baker Cancer Centre (Calgary, Canada) - Inst. 1754
Mcgill University - Dept Of Oncology (Montreal, Canada) - Inst. 1765
Cross Cancer Institute (Edmonton - Alberta, Canada) - Inst. 871
General Teaching Hospital In Prague (Prague 2, Czech Republic) - Inst. 961
Research Institute Oncology (Brno, Czech Republic) - Inst. 962
Aarhus University Hospital (Aarhus, Denmark) - Inst. 440
Herlev Hospital - University Copenhagen (Herlev, Denmark) - Inst. 406
Odense University Hospital (Odense, Denmark) - Inst. 411
Helsinki University Central Hospital (Helsinki, Finland) - Inst. 431
Turku University Central Hospital (Turku, Finland) - Inst. 432
Hopital Bichat-Claude Bernard AP-HP (Paris, France) - Inst. 191
Hopital Saint-Louis AP-HP (Paris, France) - Inst. 192
CHU Lyon - Centre Hospitalier Lyon Sud (Pierre-Benite (lyon), France) - Inst. 194
Assistance Publique - Hôpitaux de Marseille - Hopital Sainte-Marguerite (Marseille, France) - Inst. 195
Institut Gustave Roussy (Villejuif, France) - Inst. 225
Centre Alexis Vautrin (Vandoeuvre-Les-Nancy, France) - Inst. 250
C.H.R. De Lille (Lille, France) - Inst. 254
C.H.U. Ambroise Pare AP-HP (Boulogne-Billancourt, France) - Inst. 2303
Eberhard-Karls-Universitaet - Hautklinik (Tuebingen, Germany) - Inst. 3072
Medizinische Universitaet Zu Luebeck (Luebeck, Germany) - Inst. 480
Universitaetsklinikum Koeln (Koeln, Germany) - Inst. 508
Universitaetsklinikum - Essen (Essen, Germany) - Inst. 509
Universitaetsklinikum Schleswig-Holstein (Kiel, Germany) - Inst. 521
UniversitaetsMedizin Mannheim (Mannheim, Germany) - Inst. 527
Georg August Universitaet (Goettingen, Germany) - Inst. 570
Universitaets-Klinik Wuerzburg (Wuerzburg, Germany) - Inst. 576
Universitaetsklinikum Heidelberg (Heidelberg, Germany) - Inst. 578
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany) - Inst. 198
Azienda Ospedaliera Di Padova (Padova, Italy) - Inst. 725
Istituto Regina Elena (Roma, Italy) - Inst. 742
Istituto Nazionale Per La Ricerca Sul Cancro (Genova, Italy) - Inst. 776
Istituto Europeo Di Oncologia (Milano, Italy) - Inst. 3869
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori (Napoli, Italy) - Inst. 3870
Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) - Inst. 3922
Norwegian Radium Hospital (Oslo, Norway) - Inst. 841
Maria Sklodowska-Curie Memorial Cancer Centre (Warsaw, Poland) - Inst. 550
Stavropol Clinical Oncology Center - Pyatigorsk (Pyatigorsk, Russia) - Inst. 9270
Ivanovo Regional Oncology Dispensary (Ivanovo, Russia) - Inst. 9271
Tomsk Regional Oncology Dispensary (Tomsk, Russia) - Inst. 9273
Republic Clinical Oncology Dispensary of Ministry of Health of Bashkortostan Republic (Ufa, Russia) - Inst. 9274
City Clinical Oncology Dispensary (Saint-Petersburg, Russia) - Inst. 9275
Republic Clinical Oncology Dispensary of Ministry of Health of Tatarstan Republic (Kazan, Russia) - Inst. 9276
Leningrad Regional Oncology Dispensary (Saint-Petersburg, Russia) - Inst. 9277
Lipetsk Regional Oncology Dispensary (Lipetsk, Russia) - Inst. 9279
Regional Clinical Oncology Dispensary (Krasnodar, Russia) - Inst. 9280
Regional Oncology Dispensary of Minzdrav of Karelia Republic (Petrozavodsk, Russia) - Inst. 9281
S.M. Kirov Military Medical Academy (Saint-Petersburg, Russia) - Inst. 9284
Krasnoyarsk Regional Clinical Oncology Dispensary (Krasnoyarsk, Russia) - Inst. 9290
State Healthcare Institution (Izhevsk, Russia) - Inst. 9291
Itinerary Clinical Hospital on Saratov-2 Station of RZD LLC (Saratov, Russia) - Inst. 9292
Cancer Research Center (Moscow, Russia) - Inst. 6900
Hospital Universitario 12 De Octubre (Madrid, Spain) - Inst. 365
Hospital Clinic Universitari (Barcelona, Spain) - Inst. 369
Karolinska University Hospital, location Solna (Stockholm, Sweden) - Inst. 862
Universitaetsspital (Zurich, Switzerland) - Inst. 453
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, The Netherlands) - Inst. 301
Erasmus University Medical Center (Rotterdam, The Netherlands) - Inst. 302
Universitair Medisch Centrum - Academisch Ziekenhuis (Utrecht, The Netherlands) - Inst. 306
Vrije Universiteit Medisch Centrum (Amsterdam, The Netherlands) - Inst. 308
Leiden University Medical Centre (Leiden, The Netherlands) - Inst. 310
California Pacific Medical Center (San Francisco, U.S.A.) - Inst. 9095
Siteman Cancer Center (St Louis, U.S.A.) - Inst. 9103
Memorial Sloan-Kettering Cancer Center (New York, U.S.A.) - Inst. 6802
Dana-Farber Cancer Institute & Harvard Medical School (Boston, U.S.A.) - Inst. 6808
Yale University School Of Medicine (New Haven, U.S.A.) - Inst. 6834
Lutheran General Hospital / Advocate Cancer Care Center (Park Ridge, U.S.A.) - Inst. 6863
University Of Utah - Huntsman Cancer Institute (Salt Lake City, U.S.A.) - Inst. 6884
Fred Hutchison Seattle Cancer Care Alliance (Seattle, U.S.A.) - Inst. 8678
H. Lee Moffitt Cancer Center Research Institute (Tampa, U.S.A.) - Inst. 8675
The Angeles Clinic and Research Institute (Los Angeles, U.S.A.) - Inst. 9090
Vanderbilt Ingram Cancer Center (Nashville, U.S.A.) - Inst. 9091
Northern California Melanoma Center (San Francisco, U.S.A.) - Inst. 9092
Melanoma Center Atlantic Health Center (Morristown, U.S.A.) - Inst. 9093
St Luke's Health Hospital & Network (Bethlehem, U.S.A.) - Inst. 9094
Blumenthal Cancer Center (Charlotte, U.S.A.) - Inst. 9156
University of New Mexico, Cancer Care Alliance (Albuquerque, U.S.A.) - Inst. 9163
Beth Israel Deaconess Medical Center (Boston, U.S.A.) - Inst. 9225
Massachussets General Hospital Cancer Center (Boston, U.S.A.) - Inst. 9219
St Georges Hospital (London, United Kingdom) - Inst. 6961
Nottingham City Hospital (Nottingham, United Kingdom) - Inst. 6998
Mid Essex Hospitals - Broomfield Hospital (Broomfield (essex), United Kingdom) - Inst. 7085
St. James'S University Hospital (Leeds, United Kingdom) - Inst. 601
Southampton General Hospital (Southampton, United Kingdom) - Inst. 606
Protocol summaryLink provided by NCI PDQ
Protocol documents in PDF (requires password)18071.pdf
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