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 | 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 Alize Devalckeneer (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Nadine Galonde (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Alessandro Gugino (Project Manager) , EORTC Headquarters, Brussels Sven Janssen (Data Manager) , EORTC Headquarters, Brussels Michal Kicinski (Statistician) , EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Elisa Nardone (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Alessia Pochesci (Clinical Research Physician) , EORTC Headquarters, Brussels Carmen Sobrino (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Stefan Suciu (Statistician) , 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 |
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) Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis (Paris, France) Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, 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-André - 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) Gustave Roussy (Villejuif, France) Hopital de La Timone (APHM) (Marseille, France) Hospital Clinic Universitari de Barcelona (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) Krankenhaus Buxtehude (Buxtehude, Germany) Maria Sklodowska Curie - Curie’s National Institute of Oncology – National Research Institute (Warsaw, Poland) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Regina Elena National Cancer Center (Roma, Italy) Technische Universitaet Muenchen (Muenchen, Germany) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) 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) Vall d'Hebron Institut Oncologia (Barcelona, Spain) |
| Centers to be activated |
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy) Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine (Udine, Italy) Centre Hospitalier Universitaire De Poitiers (Poitiers, France) 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) IRCCS - Istituto Oncologico Veneto (Padova, Italy) Istituto Europeo di Oncologia (Milano, Italy) Istituto Europeo di Oncologia (Milano, Italy) Odense University Hospital (Odense, Denmark) Policlinico San Matteo (Pavia, Italy) Tampere University Hospital (Tampere, Finland) Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT03235245 |
| NCT number | NCT03235245 |
| EudraCT | 2017-002887-42 |
| Financial Support | Educational Grant |