Clinical Trial Details

EORTC-1612-MG

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)

Study documentation

Trial Status	Recruiting
Dates	Date of activation: 30-Oct-2018
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 Emanuel Buhrer (Project Physician) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Luminita Copaceanu (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Sven Janssen (Data Manager) , EORTC Headquarters, Brussels Michal Kicinski (Statistician) , EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) , 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 Barbara Ogrodniczak (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Felix Oppong (Statistician) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Javier Solares (Clinical Operations Manager) , EORTC Headquarters, Brussels Lien Styns (Data Manager) , EORTC Headquarters, Brussels Stefan Suciu (Statistician) , EORTC Headquarters, Brussels Cathy Van de Wiele (Data Manager) , EORTC Headquarters, Brussels Zineb Wadid (Lead CRA) , EORTC Headquarters, Brussels Leen Wijnen (Data Manager) , EORTC Headquarters, Brussels Christine de Balincourt (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer	Melanoma
Participating groups	EORTC Melanoma Group
Recruiting centers	AZ Maria Middelares (Gent, Belgium) Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare (BOULOGNE BILLANCOURT CEDEC, France) Assistance Publique - Hopitaux de Paris - Hopital Cochin (PARIS CEDEX 14, France) Assistance Publique - Hopitaux de Paris - Hopital Saint-Louis (PARIS CEDEX 10, France) Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy) Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, 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 - Hopital Sud (SALOUEL, 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 (TOURS CEDEX 9, France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Hospitalier De Pau (PAU CEDEX, France) Centre Jean Perrin (CLERMONT FERRAND CEDEX 1, 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 Universitari 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-Regina Elena National Cancer Center (Roma, 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) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Centers to be activated	Centre Hospitalier Universitaire De Poitiers (POITIERS CEDEX, France) Fondazione IRCCS - Policlinico San Matteo (Pavia, Italy) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) Istituto Europeo di Oncologia (Milano, Italy) Tampere University Hospital (Tampere, Finland)
Protocol summary	http://clinicaltrials.gov/ct/show/NCT03235245
NCT number	NCT03235245
EudraCT	2017-002887-42
Financial Support	Educational Grant