Study

EORTC-2139-MG

Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group

Study documentation Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 06-May-2022
Date Step1 close: 02-Oct-2023

Data management at EORTC

Yes

Design

Phase 3
Randomized blind

Targeted Sample size

EORTC Groups: 815 - All Groups: 815

Treatment

Drug
Encorafenib, Binimetinib

Study Staff

Alexander van Akkooi (Study Coordinator), Melanoma Institute Australia -The Poche center, Wollstonecraft
Alexander Eggermont (Study Co-Coordinator), Prinses Maxima Centrum voor Kinderoncologie, Utrecht
Mario Mandala (Study Co-Coordinator), Santa Maria della Misericordia Hospital, Perugia
Sarah Nuyens (Project Manager), EORTC Headquarters, Brussels
Anne-Sophie Govaerts (Clinical Scientist), EORTC Headquarters, Brussels
Corneel Coens (Statistician), EORTC Headquarters, Brussels
Michal Kicinski (Statistician), EORTC Headquarters, Brussels
Nitish Jha (Statistical Analyst), EORTC Headquarters, Brussels
Gaetan de Schaetzen (Clinical Operations Manager), EORTC Headquarters, Brussels
Nathalie Elaut (Data Manager), EORTC Headquarters, Brussels
Sven Janssen (Data Manager), EORTC Headquarters, Brussels
Robby Louis (Data Manager), EORTC Headquarters, Brussels
Tsvetelina Stefanova (Data Manager), EORTC Headquarters, Brussels
Lien Styns (Data Manager), EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
Katrien Baus (Admin. assistant DM), EORTC Headquarters, Brussels
Ana Joaquim (Unblinded CRP), EORTC Headquarters, Brussels
Thierry Gorlia (Unblinded statistician), EORTC Headquarters, Brussels

Type of cancer

Melanoma

Participating groups

EORTC Melanoma Group
Melanoma Institute Australia
European Association of Dermatology Oncology

Recruiting centers

A.H.Th. " Theagenio" Clinic (Thessaloniki, Greece)
APHP - Univ Paris Saclay - Hopital Ambroise Pare (Boulogne Billancourt, France)
APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
Academisch Ziekenhuis Maastricht (Maastricht, Netherlands)
Alesund Hospital (Alesund, Norway)
Alfred Hospital (Prahran, Australia)
Athens Medical Center (Athens, Greece)
Austin Health - Austin hospital (Heidelberg VIC, Australia)
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy)
Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy)
Azienda Ospedaliera Santa Croce E Carle (Cuneo, Italy)
Azienda Ospedaliera Univ Policlinico Paolo Giaccone (Palermo, Italy)
Azienda Ospedaliera Universitaria Pisana (Pisa, Italy)
Azienda Ospedaliera Universitaria Sassari (Sassari, Italy)
Azienda Sanitaria Universitaria Friuli Centrale (Ospedaliero Universitario "Santa Maria della Misericordia" ) (Udine, Italy)
BioClinic Thessaloniki (Thessaloniki, Greece)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre (BORDEAUX CEDEX, France)
CHU de Dijon - Hopital Francois Mitterand (DIJON CEDEX, France)
CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
CHU de Lille (LILLE CEDEX, France)
CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France)
CHU de Nantes - Hotel Dieu (NANTES CEDEX 1, France)
CHU de Nice - Hopital De L'Archet (NICE, France)
CHU de Rouen - Hopital Charles Nicolle (ROUEN CEDEX, France)
CHU de Saint-Etienne - Hopital Nord (Saint Priest en Jarez, France)
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE, France)
CHU de Tours - Hopital Trousseau (Chambray Les tours, France)
CLCC - Jean Perrin (CLERMONT FERRAND , France)
Centre Eugene Marquis (RENNES CEDEX, France)
Centre Hospitalier De Pau (PAU CEDEX, France)
Centre Hospitalier Universitaire De Poitiers (POITIERS CEDEX, France)
Centro Di Riferimento Oncologico (Aviano, Italy)
Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria (Lisboa, Portugal)
Centro Oncologico Korben (Buenos Aires, Argentina)
Centrum Medyczne Pratia Poznan (Dopiewo, Poland)
Chaim Sheba Medical Center (Ramat Gan, Israel)
Clinica Adventista Belgrano (Belgrano CABA, Argentina)
Clinical Centre of Kragujevac (Kragujevac, Serbia)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom)
Eastern Health - Box Hill Hospital (Box Hill, Australia)
Elbe Kliniken - Buxtehude (Buxtehude, Germany)
Erasmus MC (Rotterdam, Netherlands)
Fakultni Nemocnice Kralovske Vinohrady (Prague 10, Czech Republic)
Fakultní nemocnice Ostrava (Ostrava-Poruba, Czech Republic)
General Teaching Hospital In Prague (Prague 2, Czech Republic)
Greater Poland Cancer Centre (Poznan, Poland)
Gustave Roussy (VILLEJUIF CEDEX, France)
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz (Gyor, Hungary)
HaEmek Medical Center (Afula, Israel)
Hadassah University Hospital- Ein Kerem (Jerusalem, Israel)
Hopital de La Timone (APHM) (MARSEILLE, France)
Hospital Clinic de Barcelona (Barcelona, Spain)
Hospital Clinico Universitario - Virgen De La Arrixaca (El Palmar, Spain)
Hospital Clinico Universitario De Valencia (Valencia, Spain)
Hospital General Universitario (Valencia, Spain)
Hospital General Universitario Gregorio Maranon (Madrid, Spain)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hospital Universitario Regional de Malaga (Malaga, Spain)
Hospital Universitario Reina Sofia (Cordoba, Spain)
Hospitales HM Sanchinarro-CIOCC (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 - Fondazione Istituto Nazionale dei Tumori (Milano, Italy)
IRCCS - Istituto Oncologico Veneto (Padova, Italy)
IRCCS - Istituto Tumori "Giovanni Paolo II" (Bari, Italy)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
IRCCS Ospedale San Martino (Genova, Italy)
IRCCS Ospedale San Raffaele (Milano, Italy)
Institut Jules Bordet (Anderlecht, Belgium)
Institute Of Oncology & Radiology (Belgrade, Serbia)
Instituto Alexander Fleming (Caba Buenos Aires, Argentina)
Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
Interbalkan Medical Center (Thessaloniki, Greece)
Isala Klinieken Stichting (Zwolle, Netherlands)
Istituto Dermopatico Dell'Immacolata (Roma, Italy)
Istituto Europeo di Oncologia (Milano, Italy)
Jewish General Hospital (Montreal, Canada)
Karolinska University Hospital, location Solna (Stockholm Solna, Sweden)
Laiko General Hospital of Athens (Athens, Greece)
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital (Preston, United Kingdom)
Leiden University Medical Centre (Leiden, Netherlands)
London Regional Cancer Center (London, Canada)
M. Sklodowka-Curie National Research Institute of Oncology Gliwice Branch (Gliwice, Poland)
Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
Medical University of Graz - Dermatology (Graz, Austria)
Medical University of Vienna, University Hospital AKH Vienna (Vienna, Austria)
Melanoma Institute Australia -The Poche center (Wollstonecraft, Australia)
Metropolitan Hospital (Pireas, Greece)
National Institute Of Oncology (Budapest, Hungary)
Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care (Newcastle upon Tyne, United Kingdom)
Norrlands- Universitetssjukhus (Umea, Sweden)
Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto (Ontario), Canada)
Oncology Institute of Vojvodina (Sremska Kamenica, Serbia)
Ordensklinikum Linz-Elisabethinen (Linz, Austria)
Oslo University Hospital - Radiumhospitalet (Oslo, Norway)
Ospedale San Vincenzo - Taormina (Taormina, Italy)
Pecs University Hospital (Pecs, Hungary)
Princess Alexandra Hospital - University Of Queensland (Woolloongabba, Brisbane, Australia)
Przychodnia Lekarska Komed (Konin, Poland)
Rabin Medical Center - Tel Aviv (Petah Tikva, Israel)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Sanatorio Britanico (Santa Fe, Argentina)
Santa Maria della Misericordia Hospital (Perugia, Italy)
Semmelweis Egyetem - Dept Dermatology Venereology Dermatooncology (Budapest, Hungary)
Sir Charles Gairdner Hospital (Nedlands, Australia)
Szegedi Tudomanyegyetem, Onkoterapias Intezet (Szeged, Hungary)
The Maria Sklodowska C.M.C.C.I.O. Krakow (Krakow, Poland)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetskinikum St. Poelten (St. Poelten, Austria)
Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany)
Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany)
Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik (Heidelberg, Germany)
Universitaetsklinikum Schleswig-Holstein - Campus Kiel (Kiel, Germany)
Universitaetsklinikum Wuerzburg (Wuerzburg, Germany)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
Universitair Ziekenhuis Gent (Gent, Belgium)
University Clinical Centre Of Nis (Nis, Serbia)
University Hospital A Coruna-Hospital Teresa Herrera (A Coruna, Spain)
University Hospital Hradec Kralove (Hradec Kralove, Czech Republic)
University Hospital Of Olomouc (Olomouc, Czech Republic)
University Medical Center - Bezanijska Kosa (Belgrade, Serbia)
University Medical Center Groningen (Groningen, Netherlands)
University of Debrecen Medical Health Care Center (Debrecen, Hungary)
VITAZ- Oncology (Sint Niklaas, Belgium)
Westmead Hospital - Crown Princess Mary Cancer Center (Westmead, Australia)
Wroclaw Comprehensive Cancer Centre (Dolnoslaskie Centrum Onkologi) (Wroclaw, Poland)
ZAS Middelheim (Antwerpen, Belgium)
ZAS Palfijn (Merksem, Belgium)

Protocol summary

http://clinicaltrials.gov/study/NCT05270044

NCT number

NCT05270044

EudraCT

2021-004310-19