Study

EORTC-1325-MG

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 Back to result

Trial Status

LT-FU ongoing

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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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 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 Hospital Graz (Graz, Austria)
  • 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)

Centers to be activated

  • Region Midtjylland - Aarhus University Hospital-Skejby (Aarhus, Denmark)

Protocol summary

http://clinicaltrials.gov/study/NCT02362594

NCT number

NCT02362594

EudraCT

2014-004944-37