Clinical Trial Details
EORTC-1612-MG
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Combination of targeted therapy (Encorafenib and Binimetinib) followed by combination of immunoterapy (Ipilimumab and Nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation: an EORTC phase II randomized study (EBIN)
Trial Status | Closed to Patient Entry |
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Dates |
Date of activation: 30-Oct-2018 Date Step1 close: 11-Jul-2022 |
Data management at EORTC | Yes |
Design |
Phase 2 Randomized open label |
Targeted Sample size | EORTC Groups: 270 - All Groups: 270 |
Treatment |
Drug Ipilimumab, Nivolumab, Encorafenib, Binimetinib |
Study Staff |
Caroline Robert (Study Coordinator) , Gustave Roussy, VILLEJUIF CEDEX Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Emanuel Buhrer (Project Physician) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Florence Dujardin (Data Manager) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Lore Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Sven Janssen (Data Manager) , EORTC Headquarters, Brussels Michal Kicinski (Statistician) , EORTC Headquarters, Brussels Robby Louis (Data Manager) , EORTC Headquarters, Brussels Juliette Ly (Project Manager) , EORTC Headquarters, Brussels Anja Mestnik (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Zara Nasir (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Barbara Ogrodniczak (Junior Clinical Operations Manager) , , Felix Oppong (Statistician) , EORTC Headquarters, Brussels Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Nathalie Ropson (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Lien Styns (Data Manager) , EORTC Headquarters, Brussels Carla Sureda (Clinical Operations Manager) , EORTC Headquarters, Brussels Cathy Van de Wiele (Data Manager) , EORTC Headquarters, Brussels Zineb Wadid (Clinical Research Associate/Monitor) , 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 Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy) Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy) Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine (Udine, Italy) CHRU de Besancon - Hopital Jean Minjoz (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 Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France) CHU de Nice - Hopital De L'Archet (NICE, France) CHU de Saint-Etienne - Hopital Nord (Saint Priest en Jarez, France) CHU de Tours - Hopital Trousseau (Chambray Les tours, France) CLCC - Jean Perrin (CLERMONT FERRAND , France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Hospitalier De Pau (PAU CEDEX, France) Centre Leon Berard (Lyon, France) Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany) East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom) Elbe Kliniken - Buxtehude (Buxtehude, Germany) Gustave Roussy (VILLEJUIF CEDEX, France) Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario La Paz (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) IRCCS - Fondazione G. Pascale (Napoli, Italy) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS-Regina Elena National Cancer Center (Roma, Italy) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Odense University Hospital (Odense C, Denmark) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany) Universitaetsklinikum Wuerzburg (Wuerzburg, Germany) Universitaetsklinikum Wuerzburg (Wuerzburg, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) |
Protocol summary | http://clinicaltrials.gov/study/NCT03235245 |
NCT number | NCT03235245 |
EudraCT | 2017-002887-42 |
Financial Support | Educational Grant |