Study

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 Back to result

Trial Status

Closed to Patient Entry

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
  • 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, 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-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)

Protocol summary

http://clinicaltrials.gov/study/NCT03235245

NCT number

NCT03235245

EudraCT

2017-002887-42