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ACTIVE NOT RECRUITING
NCT05270044
PHASE3

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

Sponsor: Pierre Fabre Medicament

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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