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 |
| Treatment |
Drug Ipilimumab, Nivolumab, Encorafenib, Binimetinib |
| Study Staff |
Caroline Robert (Study Coordinator) , Gustave Roussy, Villejuif Mariclaire Conflitti (Regulatory Affairs Administrator) mariclaire.conflitti (at) eortc.org, EORTC Headquarters, Brussels Alize Devalckeneer (Junior Clinical Operations Manager) alize.devalckeneer (at) eortc.org, EORTC Headquarters, Brussels Nadine Galonde (Regulatory Affairs Manager) nadine.galonde (at) eortc.org, EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at) eortc.org, EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) anne-sophie.govaerts (at) eortc.org, EORTC Headquarters, Brussels Sven Janssen (Data Manager) sven.janssen (at) eortc.org, EORTC Headquarters, Brussels Michal Kicinski (Statistician) michal.kicinski (at) eortc.org, EORTC Headquarters, Brussels Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at) eortc.org, EORTC Headquarters, Brussels Eluisa Perna (Pharmacovigilance Manager) eluisa.perna (at) eortc.org, EORTC Headquarters, Brussels Alessia Pochesci (Clinical Research Physician) alessia.pochesci (at) eortc.org, EORTC Headquarters, Brussels Stefan Suciu (Statistician) stefan.suciu (at) eortc.org, EORTC Headquarters, Brussels Leen Wijnen (Data Manager) leen.wijnen (at) eortc.org, EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) christine.debalincourt (at) eortc.org, EORTC Headquarters, Brussels Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at) eortc.org, 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) CHRU de Besancon - Hopital Jean Minjoz (Besancon, France) CHRU de Lille (Lille, France) CHU Amiens - Hopital Sud (Salouel, France) CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France) CHU de Grenoble - La Tronche - Hôpital 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 - Hôpital Robert Debré (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) Gustave Roussy (Villejuif, France) Hopital St. Eloi (Montpellier, France) Hospital Clinic Universitari de Barcelona (Barcelona, Spain) Hôpital de La Timone (APHM) (Marseille, France) 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) Maria Sklodowska-Curie Memorial Cancer Centre (Warsaw, Poland) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) |
| Centers to be activated |
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) Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany) East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom) HELIOS Klinikum Erfurt (Erfurt, Germany) Helsinki University Central Hospital - Dept of Oncology (Helsinki, Finland) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hospital Universitario La Paz (Madrid, Spain) Istituto Europeo di Oncologia (Milano, Italy) Istituto Europeo di Oncologia (Milano, Italy) Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (Napoli, Italy) Istituto Oncologico Veneto IRCCS (Padova, Italy) Krankenhaus Buxtehude (Buxtehude, Germany) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Odense University Hospital (Odense, Denmark) Regina Elena National Cancer Center (Roma, Italy) Tampere University Hospital (Tampere, Finland) Technische Universitaet Muenchen (Muenchen, Germany) Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany) Universitaetsklinikum Wuerzburg (Wuerzburg, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) Vall d'Hebron Institut d’Oncologia (Barcelona, Spain) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT03235245 |
| NCT number | NCT03235245 |
| EudraCT | 2017-002887-42 |