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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)

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
Giuliana Crucitti (Regulatory Affairs Manager) giuliana.crucitti (at), EORTC Headquarters, Brussels
Alize Devalckeneer (Junior Clinical Operations Manager) alize.devalckeneer (at), EORTC Headquarters, Brussels
Nadine Galonde (Regulatory Affairs Manager) nadine.galonde (at), EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at), EORTC Headquarters, Brussels
Anne-Sophie Govaerts (Clinical Scientist) anne-sophie.govaerts (at), EORTC Headquarters, Brussels
Alessandro Gugino (Project Manager) alessandro.gugino (at), EORTC Headquarters, Brussels
Sven Janssen (Data Manager) sven.janssen (at), EORTC Headquarters, Brussels
Michal Kicinski (Statistician) michal.kicinski (at), EORTC Headquarters, Brussels
Eleni Mandila (Regulatory Affairs Administrator) eleni.mandila (at), EORTC Headquarters, Brussels
Diem Chi Nguyen (Pharmacovigilance Manager) diemchi.nguyen (at), EORTC Headquarters, Brussels
Carmen Sobrino (Clinical Research Associate/Monitor) carmen.sobrino (at), EORTC Headquarters, Brussels
Lien Styns (Data Manager) lien.styns (at), EORTC Headquarters, Brussels
Stefan Suciu (Statistician) stefan.suciu (at), EORTC Headquarters, Brussels
Leen Wijnen (Data Manager) leen.wijnen (at), EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at), 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, France)
Assistance Publique - Hopitaux de Paris - Hopital Cochin (Paris, France)
Assistance Publique - Hopitaux de Paris - Hopital Saint-Louis (Paris, France)
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, France)
CHRU de Lille (Lille, France)
CHU Amiens - Hopital Sud (Salouel, France)
CHU Montpellier-Hopital St. Eloi (Montpellier, France)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (Bordeaux, France)
CHU de Grenoble - La Tronche - Hopital A. Michallon (Grenoble, France)
CHU de Limoges - Hopital Dupuytren (Limoges, France)
CHU de Lyon - Hopital Lyon Sud (Pierre-Benite (Lyon), France)
CHU de Nice - Hopital De L'Archet (Nice, France)
CHU de Reims - Hopital Robert Debre (Reims, France)
CHU de Saint-Etienne - Hopital Nord (Saint Priest en Jarez, France)
CHU de Tours - Hopital Trousseau (Tours, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Hospitalier De Pau (Pau, France)
Centre Jean Perrin (Clermont-Ferrand, France)
Centre Leon Berard (Lyon, France)
East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
Elbe Kliniken - Buxtehude (Buxtehude, Germany)
Gustave Roussy (Villejuif, France)
Hopital de La Timone (APHM) (Marseille, 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)
Technische Universitaet Muenchen (Muenchen, Germany)
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)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Centers to be activated Aarhus University Hospital-Skejby (Aarhus, Denmark)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy)
Centre Hospitalier Universitaire De Poitiers (Poitiers, France)
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
HELIOS Klinikum Erfurt (Erfurt, Germany)
Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
IRCCS - Istituto Nazionale dei Tumori (Milano, Italy)
Istituto Europeo di Oncologia (Milano, Italy)
Odense University Hospital (Odense, Denmark)
Policlinico San Matteo (Pavia, Italy)
Tampere University Hospital (Tampere, Finland)
Protocol summary
NCT number NCT03235245
EudraCT 2017-002887-42