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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

815

Participants

Timeline

Start Date

May 2, 2022

Primary Completion Date

March 31, 2027

Study Completion Date

May 2, 2035

Conditions
Melanoma
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.

Trial Locations (155)

1070

Institut Jules Bordet, Anderlecht

1085

Semmelweis Egyetem, Budapest

1090

AKH - Medizinische Universität Wien, Vienna

Universitair Ziekenhuis Brussel, Brussels

1122

Orszagos Onkologiai Intezet, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

1692

Johese Clinical Research: Midstream, Centurion

2000

Sanatorio Britanico S.A., Rosario

2020

ZNA Middelheim, Antwerp

2065

Melanoma Institute Australia, Wollstonecraft

2145

Westmead Hospital, Sydney

2170

ZNA, Merksem

2196

Sandton Oncology Medical Group, Johannesburg

3084

Austin Health, Heidelberg

3100

Universitätsklinikum St.Pölten-Lilienfeld, Sankt Pölten

3128

Box Hill Hospital, Box Hill

3181

The Alfred Hospital, Prahran

4020

Krankenhaus der Elisabethinen Linz, Linz

4032

Debreceni Egyetem, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

5006

Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital, North Adelaide

5530

CHU UCL Namur, Yvoir

6009

Hollywood Private Hospital, Nedlands

Sir Charles Gairdner Hospital, Nedlands

6017

Ålesund Hospital, Ålesund

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7632

Pecsi Tudomanyegyetem, Pécs

8036

Landeskrankenhaus - Universitaetsklinikum Graz, Graz

8091

Universitaetsspital Zuerich, Zurich

9000

UZ Gent, Ghent

9023

Petz Aladar Egyetemi Oktato Korhaz, Győr

9100

Vitaz, Sint-Niklaas

9301

National Hospital Oncology, Bloemfontein

10126

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino

11000

"Clinical Center Bezanijska kosa", Belgrade

Institute of Oncology and Radiology of Serbia, Belgrade

Military Medical Academy, Belgrade

11527

General Hospital of Athens Laiko, Athens

12100

Azienda Sanitaria Ospedaliera S.Croce e Carle, Cuneo

13385

Hôpital de la Timone, Marseille

14004

Hospital Universitario Reina Sofia, Córdoba

16132

IRCCS Ospedale Policlinico San Martino, Genova

17176

Karolinska University Hospital, Stockholm

18000

Clinical Center Nis, Niš

18547

Metropolitan Hospital, Neo Faliro

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

IEO Istituto Europeo di Oncologia, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

21079

CHU de Dijon - Hôpital du Bocage, Dijon

21204

Oncology Institute of Vojvodina, Kamenitz

21614

Elbekliniken Buxtehude GmbH, Buxtehude

24105

Universitaetsklinikum Schleswig-Holstein, Kiel

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

31059

Institut Claudius Regaud - Oncopole, Toulouse

33075

CHU de Bordeaux - Hôpital Saint André, Bordeaux

33081

IRCCS Centro di Riferimento Oncologico, Aviano

33100

Azienda Sanitaria Universitaria Friuli Centrale, Udine

34000

Clinical Center Kragujevac, Kragujevac

35042

CRLCC Eugene Marquis, Rennes

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

37170

CHU Tours - Hôpital Trousseau, Chambray-lès-Tours

38700

CHU de Grenoble - Hôpital André Michallon, La Tronche

42055

CHU Saint Etienne - Hôpital Nord, Saint-Étienne-de-Montluc

44093

CHU Nantes - Hôtel Dieu, Nantes

46010

Hospital Clinico Universitario de Valencia, Valencia

46014

Hospital General Universitario de Valencia, Valencia

47014

"IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori Dino Amadori - IRST", Meldola

53100

A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena

54622

Bioclinic Thessaloniki, Thessaloniki

54639

"Anticancer Hospital of Thessaloniki Theagenio", Thessaloniki

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

57001

Interbalkan Hospital of Thessaloniki, Thessaloniki

59037

Hopital Claude Huriez - CHU Lille, Lille

63000

CAC Clermont-Ferrand Centre Jean Perrin, Clermont-Ferrand

64046

Centre Hospitalier de Pau - Hôpital François Mitterrand, Pau

69120

Universitaetsklinikum Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari

75010

Hôpital Saint-Louis, Paris

76031

CHU de Rouen - Hôpital Charles Nicolle, Rouen

79900

Fakultni nemocnice Olomouc, Olomouc

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Naples

86021

CHU Poitiers - Hôpital la Milétrie, Poitiers

90127

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo

92100

Hôpital Ambroise Paré, Boulogne-Billancourt

94805

Institut Gustave Roussy, Villejuif

97080

Universitaetsklinikum Wuerzburg, Würzburg

98039

Ospedale San Vincenzo, Taormina

200542

S.C Centrul de Oncologie Sf. Nectarie S.R.L, Craiova

400641

S.C Medisprof S.R.L, Cluj-Napoca

700483

Institutul Regional de Oncologie Iasi, Iași

C1426

Centro Oncologico Korben, CABA

B7600FYK

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

C1121ABE

Fundacion CIDEA, Ciudad Autonoma Bs As

S2000KZE

Instituto de Oncologia de Rosario, Rosario

C1118AAT

Hospital Aleman, Ciudad Autonoma Buenos Aires

C1426ANZ

Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma Buenos Aires

C1430EGF

Clinica Adventista Belgrano, Ciudad Autonoma Buenos Aires

41950-640

AMO - Assistência Multidisciplinar em Oncologia, Salvador

81520-060

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba

86015-520

Instituto de Cancer de Londrina, Londrina

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

90110-270

HGB - Hospital Giovanni Battista - Mãe de Deus Center, Porto Alegre

96810-110

Instituto de Oncologia Saint Gallen, Santa Cruz do Sul

88034-000

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina, Florianópolis

17210-120

Fundação Doutor Amaral Carvalho, Jaú

09060-870

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

01509-900

A. C. Camargo Cancer Center, São Paulo

N6A 5W9

London Health Sciences Centre (LHSC) - Victoria Hospital, London

M4N 3M5

Toronto Sunnybrook Hospital, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3T 1E2

CIUSSS du Centre Ouest de l'lle de Montreal, Montreal

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna fakultni nemocnice v Praze, Prague

06202

CHU Nice - Hopital de l Archet 2, Nice

01307

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

06156

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia, Perugia

00144

Istituto Nazionale Tumori Regina Elena IRCCS, Roma

00167

IDI-Istituto Dermopatico dell'Immacolata IRCCS, Roma

07100

Policlinico Universitario di Sassari, Sassari

1066 CX

Antoni van Leeuwenhoek, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen (UMCG), Groningen

2333 ZA

Leids Universitair Medisch Centrum, Leiden

6202 AZ

Maastricht University Medical Center, Maastricht

6525 GA

Radboudumc, Nijmegen

3015 GD

Erasmus MC, Rotterdam

3508 GA

UMC Utrecht, Utrecht

8025 AB

Isala, Zwolle

0424

Oslo University Hospital, Oslo

44-102

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Gliwice

62-500

Przychodnia Lekarska Komed, Konin

31-115

Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Krakow

61-866

Wielkopolskie Centrum Onkologii, Poznan

60-185

Centrum Medyczne Pratia Poznan, Skórzewo

02-781

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw

53-413

Dolnoslaskie Centrum Onkologii, Wroclaw

1099-023

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto

08916

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

08908

ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

901 87

Norrlands Universitetssjukhus, Umeå

PR2 9HT

Royal Preston Hospital, Preston

NE7 7DN

Northern Centre for Cancer Care, Newcastle upon Tyne

All Listed Sponsors
collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

lead

Pierre Fabre Medicament

INDUSTRY

NCT05270044 - Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. | Biotech Hunter | Biotech Hunter