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Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
Sponsor: Pierre Fabre Medicament
Summary
The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
815
Start Date
2022-05-02
Completion Date
2035-05-02
Last Updated
2023-11-22
Healthy Volunteers
No
Conditions
Interventions
Encorafenib and Binimetinib
Encorafenib 450 mg (6 × 75 mg capsules) once daily (QD) and binimetinib 45 mg (3 x 15 mg tablets) twice daily (BID) orally for a maximum of 12 months.
Placebo to match Encorafenib ; Placebo to match Binimetinib
Encorafenib (6 × 75 mg placebo capsules) QD and binimetinib (3 × 15 mg placebo tablets) BID placebos orally for a maximum of 12 months.
Locations (155)
Centro Oncologico Korben
CABA, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Fundacion CIDEA
Ciudad Autonoma Bs As, Ciudad Autonoma Buenos Aires, Argentina
Sanatorio Britanico S.A.
Rosario, Santa Fe Province, Argentina
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, Argentina
Hospital Aleman
Ciudad Autonoma Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Westmead Hospital
Sydney, New South Wales, Australia
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital
North Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Prahran, Victoria, Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Landeskrankenhaus - Universitaetsklinikum Graz
Graz, Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria
Universitätsklinikum St.Pölten-Lilienfeld
Sankt Pölten, Austria
AKH - Medizinische Universität Wien
Vienna, Austria
Institut Jules Bordet
Anderlecht, Belgium
ZNA Middelheim
Antwerp, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
ZNA
Merksem, Belgium
Vitaz
Sint-Niklaas, Belgium
CHU UCL Namur
Yvoir, Belgium
AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Paraná, Brazil
Instituto de Cancer de Londrina
Londrina, Paraná, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, Brazil
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis, Santa Catarina, Brazil
Fundação Doutor Amaral Carvalho
Jaú, São Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Ontario, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CIUSSS du Centre Ouest de l'lle de Montreal
Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
CHU Nice - Hopital de l Archet 2
Nice, Alpes Maritimes, France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
CHU de Dijon - Hôpital du Bocage
Dijon, Cote dÝOr, France
CHU de Bordeaux - Hôpital Saint André
Bordeaux, Gironde, France
Institut Claudius Regaud - Oncopole
Toulouse, Haute Garonne, France
Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts De Seine, France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, Indre Et Loire, France
CHU de Grenoble - Hôpital André Michallon
La Tronche, Isere, France
CHU Nantes - Hôtel Dieu
Nantes, Loire Atlantique, France
Hopital Claude Huriez - CHU Lille
Lille, Nord, France
Hôpital Saint-Louis
Paris, Paris, France
CHU Saint Etienne - Hôpital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
CAC Clermont-Ferrand Centre Jean Perrin
Clermont-Ferrand, Puy De Dome, France
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, Pyrenees Atlantiques, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, France
Institut Gustave Roussy
Villejuif, Val De Marne, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, Vienne, France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany
Elbekliniken Buxtehude GmbH
Buxtehude, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
General Hospital of Athens Laiko
Athens, Greece
Metropolitan Hospital
Neo Faliro, Greece
Bioclinic Thessaloniki
Thessaloniki, Greece
Anticancer Hospital of Thessaloniki " Theagenio"
Thessaloniki, Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, Greece
Semmelweis Egyetem
Budapest, Hungary
Orszagos Onkologiai Intezet
Budapest, Hungary
Debreceni Egyetem
Debrecen, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary
Pecsi Tudomanyegyetem
Pécs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary
IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST
Meldola, Forli - Cesena, Italy
Ospedale San Vincenzo
Taormina, Messina, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Napoli, Italy
IRCCS Centro di Riferimento Oncologico
Aviano, Pordenone, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Italy
Azienda Sanitaria Ospedaliera S.Croce e Carle
Cuneo, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Ospedale San Raffaele
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Roma, Italy
IDI-Istituto Dermopatico dell'Immacolata IRCCS
Roma, Italy
Policlinico Universitario di Sassari
Sassari, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Radboudumc
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Isala
Zwolle, Netherlands
Ålesund Hospital
Ålesund, Norway
Oslo University Hospital
Oslo, Norway
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Gliwice, Poland
Przychodnia Lekarska Komed
Konin, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Krakow, Poland
Wielkopolskie Centrum Onkologii
Poznan, Poland
Centrum Medyczne Pratia Poznan
Skórzewo, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
S.C Medisprof S.R.L
Cluj-Napoca, Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
Clinical Center "Bezanijska kosa"
Belgrade, Serbia
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Oncology Institute of Vojvodina
Kamenitz, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinical Center Nis
Niš, Serbia
National Hospital Oncology
Bloemfontein, Free State, South Africa
Johese Clinical Research: Midstream
Centurion, Gauteng, South Africa
Sandton Oncology Medical Group
Johannesburg, Gauteng, South Africa
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Karolinska University Hospital
Stockholm, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden
Universitaetsspital Zuerich
Zurich, Switzerland
Royal Preston Hospital
Preston, Lancashire, United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne, Tyne & Wear, United Kingdom