A trial to evaluate whether encorafenib in combination with binimetinib is effective and safe in participants with high risk Stage II BRAF-mutated melanoma

Logo COLUMBUS

Adjuvant encorafenib & binimetinib vs. placebo in resected stage II BRAF V600E/K mutated melanoma: a randomized triple-blind Phase III Study in collaboration with the EORTC Melanoma Group.

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Status
Status :
Active not recruiting
Type of study
Phase III
Min. Age
18
Years old
Max. Age
-
Gender
All

Brief summary

The COLUMBUS-AD is a Phase III clinical trial designed to evaluate how effective and safe a BRAF/MEK inhibitor combination therapy is at preventing melanoma returning (local relapse) or spreading to a distant area (metastasis) in comparison to placebo. The trial addresses to patients with high-risk stage II (IIB/IIC) BRAF V600E/K melanoma soon after their tumors are completely removed by surgery.
The BRAF inhibitor that will be used in the study is called encorafenib, and the MEK inhibitor is called binimetinib.

Therapeutic area :
Oncology
Disease :
Stage IIB/IIC (high risk) BRAF V600 E/K Melanoma
Study medication :
Encorafenib (BRAFTOVI®) - Binimetinib (MEKTOVI®)
Phase : Phase III
Start Date :
18 May 2022
Planned Primary Completion Date  :
31 March 2027
End Date / Planned study Completion Date :
May 2035
Study ID : W0090GE303_EORTC 2139_MG
EudraCT/CTIS number : 2021-004310-19
CT.gov Number : NCT05270044
Countries :
Argentina
Australia
Austria
Belgium
Brazil
Canada
Czech Republic
France
Germany
Greece
Hungary
Israel
Italy
Netherlands
Norway
Poland
Portugal
Serbia
South Africa
Spain
Sweden
Switzerland
United Kingdom

Find out where the clinical trial is conducted

1

Complejo Hospitalario Universitario A Coruña

As Xubias, 84
15006 A Coruna
Spain

2

Centro de Investigaciones Medicas Mar del Plata

Av. Colón 3083, 1 y 5to piso
B7600FYK Mar del plata
Argentina

3

Athens Medical Center

Distomou 5-7
15125 Athens
Greece

Google Map

4

Universitaetsklinikum Tuebingen

Liebermeister Str. 25
72076 Tuebingen
Germany

5

Singleton Hospital

Sketty Lane
Swansea
SA2 8QA
United Kingdom

6

Royal Marsden Hospital

Downs Road
Sutton
SM2 5PT
United Kingdom

7

LKH - Universitätsklinikum der PMU Salzburg

Müllner Hauptstraße 48
5020 Salzburg
Austria

8

CHU de Rouen - Hôpital Charles Nicolle

1 rue de Germont
76000 Rouen
France

9

Istituto Nazionale Tumori Regina Elena IRCCS

Via Elio Chianesi, 53
00144 roma
Italy

10

Klinikum rechts der Isar der TU Muenchen

Biedersteiner Straße 29
80802 Muenchen
Germany

11

Linköping University Hospital

University Hospital
58185 Linkoping
Sweden

12

UZ Leuven

Herestraat 49
3000 Leuven
Belgium

13

Universitaetsklinikum Leipzig AoeR

Philipp-Rosenthal-Strasse 23
04103 Leipzig
Germany

14

HELIOS Klinikum Krefeld

Lutherplatz 40
47805 Krefeld
Germany

15

Cancer Centre of Southeastern Ontario at Kingston General Hospital

25 King Street West
Kingston ON K7L 5P9
Canada

16

Icon Cancer Centre Hobart

2 Melville Street
Hobart 7000
Australia

17

Q.E. II Health Sciences Centre

5820 University Avenue
Halifax B3H 1V7
Canada

18

Frankston Hospital

2 Hastings Rd
Frankston VIC 3199
Australia

19

Universitaetsklinikum Frankfurt Goetheuniversitaet

Theodor-Stern-Kai 7
60590 Frankfurt
Germany

20

Universitaetsklinikum Essen

Hufelandstrasse 55
45147 Essen
Germany

21

Military Medical Academy

Crnotravska 17
11000 Belgrade
Serbia

22

Universitaetsspital Basel

Petersgraben 4
4031 Basel
Switzerland

23

Amsterdam UMC, Locatie VUMC

De Boelelaan 1117
1081 HV Amsterdam
Netherlands

24

Royal Preston Hospital

Sharoe Green Lane
Preston
PR2 9HT
United Kingdom

25

Churchill Hospital

Old Road
Oxford
OX3 7LE
United Kingdom

26

Northern Centre for Cancer Care

Freeman Road
Newcastle upon tyne
NE7 7DN
United Kingdom

27

Mount Vernon Hospital

Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

28

Odesa Regional Oncologic Dispensary

32, Nezhdanovoy st.
Odesa
65055
Ukraine

29

Medical Clinic Innovacia, LLC

69 A Vitryanogo Str
Kiev
07352
Ukraine

30

CHI Kharkiv Regional Clinical Oncological Center

4, Lisoparkivska St.
Kharkiv
61070
Ukraine

31

National Institute of Cancer

33/43, Lomonosova St.
Kyiv
03022
Ukraine

32

MI Kirovograd Regional Oncological Dispensary

1, Yaltinska St.
Kropyvnytskyi
25011
Ukraine

33

CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU

20, Hryboiedova St.
Uzhgorod
88000
Ukraine

34

SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine

1,Balakireva entrance
Kharkiv
61103
Ukraine

35

CNE“City Clin Hosp#4”of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

31, Blyzhnia St.
Dnipro
49102
Ukraine

36

Universitaetsspital Zuerich

Gloriastrasse 31
8091 Zuerich
Switzerland

37

Norrlands Universitetssjukhus

By 10, Lungmedicin
901 87 Umea
Sweden

38

Karolinska University Hospital

Karolinska University Hsp
17176 Stockholm
Sweden

39

Hospital Universitario Ramon y Cajal

Ctra. Colmenar Viejo, km 9,100
28034 Madrid
Spain

40

Hospital Universitario Reina Sofia

Avda Menendez Pidal,
14004 Cordoba
Spain

41

Hospital Universitario 12 de Octubre

Carretera De Andalucia, Km - 5.4
28041 Madrid
Spain

42

Centro Integral Oncologico Clara Campal

Oña, 10
28050 Madrid
Spain

43

ICO Lhospitalet Hospital Duran I Reynals

Avenida Gran Via de l'Hospitalet, 199-203
08908 Barcelona
Spain

44

Hospital Universitari Vall d'Hebron

Passeig Vall d'Hebron, 119-129
08035 Barcelona
Spain

45

Hospital General Universitario Gregorio Marañon

C/ Dr Esquerdo 46,
28007 Madrid
Spain

46

Hospital Clinico Universitario de Valencia

Avenida Blasco Ibañez, 17
46010 Valencia
Spain

47

Hospital Clinic de Barcelona

Carrer Villarroel 170
08036 Barcelona
Spain

48

ICO Badalona - Hospital Universitari Germans Trias i Pujol

Carretera del Canyet s/n
08916 Badalona
Spain

49

Hospital Regional Universitario de Malaga

Avenida Carlos Haya, s/n
29010 Malaga
Spain

50

Hospital Universitario Virgen de la Arrixaca

Crta. Madrid-Cartagena s/n
30120 El palmar
Spain

51

Hospital General Universitario de Valencia

Avenida Tres Cruces, s/n
46014 Valencia
Spain

52

Johese Clinical Research: Midstream

Midstream Hill Medical Park Room 103 & 211
Centurion
1692
South Africa

53

National Hospital Oncology

Roth Avenue
Bloemfontein
9301
South Africa

54

Wits Clinical Research

17 Eton Road, Medical Oncology Practice
Johannesburg
2193
South Africa

55

Sandton Oncology Medical Group

200 Rivonia Road,
Johannesburg
2196
South Africa

56

University Clinical Center Nis

Bul. Zorana Djindjica 48
18000 Nis
Serbia

57

University Clinical Center Kragujevac

Zmaj Jovina 30
34000 Kragujevac
Serbia

58

Institute of Oncology and Radiology of Serbia

Pasterova 14
11000 Belgrade
Serbia

59

Oncology Institute of Vojvodina

Put Dr Goldmana 4
21204 Sremska kamenica
Serbia

60

Clinical Hospital Center "Bezanijska kosa"

Bezanijska kosa BB
11000 Belgrade
Serbia

61

SPb SBIH "City Clinical Oncological Dispensary"

3/5,2nd Berezovaya alleya
Saint petersburg
197022
Russia

62

FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

23 Kashirskoye shosse
Moscow
115478
Russia

63

BHI of Omsk region “Clinical Oncology Dispensary”

9/1, Zavertyaeva str.
Omsk
644013
Russia

64

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

Avenida Professor Egas Moniz
1649-035 Lisboa
Portugal

65

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Rua Dr. António Bernardino de Almeida
4200-072 Porto
Portugal

66

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

Rua Professor Lima Basto
1099-023 Lisboa
Portugal

67

Dolnośląskie Centrum Onkologii Pulmonologii I Hematologii

Pl. Hirszfelda 12
53-413 Wroclaw
Poland

68

Centrum Medyczne Pratia Poznan

ul. Poznańska 14,
60-185 Skorzewo
Poland

69

PIB-NIO-Warsaw

ul. Roentgena 5
02-781 Warszawa
Poland

70

Wielkopolskie Centrum Onkologii

ul. Garbary 15
61-866 Poznan
Poland

71

Przychodnia Lekarska Komed

ul. Wojska Polskiego 6
62-500 Konin
Poland

72

PIB-NIO- Gliwice

Ul. Wybrzeze Armii Krajowej 15
44-102 Gliwice
Poland

73

PIB-NIO-Krakow

ul. Garncarska 11
31-115 Krakow
Poland

74

Oslo University Hospital

Postboks 4953 Nydalen
0424 Oslo
Norway

75

Ålesund Hospital

Åsehaugen 5
6017 Alesund
Norway

76

Erasmus MC

Dr. Molewaterplein 40
3015 GD Rotterdam
Netherlands

77

Antoni van Leeuwenhoek

Plesmanlaan 121
1066 CX Amsterdam
Netherlands

Google Map

78

Isala

Dokter van Heesweg 2
8025 AB Zwolle
Netherlands

79

Leids Universitair Medisch Centrum

2 Albinusdreef
2333 ZA Leiden
Netherlands

80

UMC Utrecht

Heidelberglaan 100
3584 CX Utrecht
Netherlands

81

Radboudumc

Zuid 10, Geert Grooteplein
6525 GA Nijmegen
Netherlands

82

Universitair Medisch Centrum Groningen (UMCG)

Hanzeplein 1
9713 GZ Groningen
Netherlands

83

Maastricht University Medical Center

P. Debyelaan 25
6202 AZ Maastricht
Netherlands

84

IRCCS Ospedale Policlinico San Martino

Largo Rosanna Benzi, 10
16132 Genova
Italy

85

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Via del Vespro, 129
90127 Palermo
Italy

86

IEO Istituto Europeo di Oncologia

Via Ripamonti 435,
20141 Milano
Italy

87

Policlinico Universitario di Sassari

Viale San Pietro
07100 Sassari
Italy

88

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

Via Cherasco 23
10126 Torino
Italy

89

Azienda Sanitaria Ospedaliera S.Croce e Carle

Via Michele Coppino, 26
12100 Cuneo
Italy

90

Azienda Sanitaria Universitaria Friuli Centrale

VIA POZZUOLO 330
33100 Udine
Italy

91

Azienda Ospedaliero Universitaria Pisana

Via Roma 67
56126 Pisa
Italy

92

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

Viale Mario Bracci, 12
53100 Siena
Italy

93

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

Piazzale Giorgio Menghini, 1
06156 Perugia
Italy

94

IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST

Via P. Maroncelli
47014 Meldola
Italy

95

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

Piazza OMS, 1
24127 Bergamo
Italy

96

Ospedale San Vincenzo

Contrada Sirina
98039 Taormina
Italy

97

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Viale Orazio Flacco, 65
70124 Bari
Italy

98

Fondazione IRCCS Istituto Nazionale dei Tumori

Via Giacomo Venezian, 1
20133 Milano
Italy

99

IDI-Istituto Dermopatico dell'Immacolata IRCCS

Via dei Monti di Creta, 104
00167 Roma
Italy

100

IOV - Istituto Oncologico Veneto IRCCS

Via Gattamelata, 64.
35128 Padova
Italy

101

Ospedale San Raffaele

Via Olgettina, 60
20132 Milano
Italy

102

IRCCS Centro di Riferimento Oncologico

Via Gallini, 2
33081 Aviano
Italy

103

Istituto Nazionale Tumori Fondazione G. Pascale

Via Mariano Semmola,
80131 Naples
Italy

104

Chaim Sheba Medical Center

Tel Hashomer
Ramat gan 5262001
Israel

105

Rabin Medical Center-Beilinson Campus

39 Jabotinski st.
Petach tikva 4941492
Israel

106

Hadassah University Hospital - Ein Kerem

Machon sharet institute, Level -1
Jerusalem 9112001
Israel

107

HaEmek Medical Center

Yitzhak Rabin Ave.
Afula 18101
Israel

108

Gyormosonsopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Gyor
Vasvari Pal u. 2-4
9024
Hungary

109

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged
Koranyi Fasor 6.
6720
Hungary

110

Orszagos Onkologiai Intezet

Budapest
Rath Gyorgy u. 7-9.
1122
Hungary

111

Pecsi Tudomanyegyetem

Pecs
Akac u. 1.
7632
Hungary

112

Semmelweis Egyetem

Budapest
Maria u. 41.
1085
Hungary

113

General Hospital of Athens Laiko

17, Agiou Thoma
11527 Athens
Greece

114

Debreceni Egyetem

Debrecen
Nagyerdei krt 98.
4032
Hungary

115

Interbalkan Hospital of Thessaloniki

10, Asklipios Str.
57001 Thessaloniki
Greece

116

Bioclinic Thessaloniki

86 Mitropoleos
54622 Thessaloniki
Greece

117

Metropolitan Hospital

9 Ethnarchou Makariou & El Venizelou
18547 Neo faliro
Greece

118

Anticancer Hospital of Thessaloniki " Theagenio"

2 Alex. Symeonidi Str.
54639 Thessaloniki
Greece

119

Universitaetsklinikum Wuerzburg

Josef-Schneider-Strasse 2
97080 Wuerzburg
Germany

120

Elbekliniken Buxtehude GmbH

Am Krankenhaus 1
21614 Buxtehude
Germany

121

Universitaetsklinikum Carl Gustav Carus TU Dresden

Fetscherstraße 74,
01307 Dresden
Germany

122

Universitaetsklinikum Heidelberg

Im Neuenheimer Feld 460, NCT
69120 Heidelberg
Germany

123

Universitaetsklinikum Schleswig-Holstein

Arnold-Heller-Strasse 3
24105 Kiel
Germany

124

Universitaetsklinikum Hamburg-Eppendorf

Martinistrasse 52
20246 Hamburg
Germany

125

Hôpital Ambroise Paré

9 Avenue Charles de Gaulle
92100 Boulogne billancourt
France

126

Institut Gustave Roussy

114 rue Edouard Vaillant
94805 Villejuif
France

127

CHU de Grenoble - Hôpital André Michallon

Boulevard de la Chantourne
38700 La tronche
France

128

CHU Nantes - Hôtel Dieu

38 boulevard Jean Monnet
44093 Nantes
France

129

CRLCC Eugene Marquis

Avenue de la Bataille Flandres Dunkerque
35042 Rennes
France

130

CHU Saint Etienne - Hôpital Nord

Avenue Albert Raimond
42055 Saint etienne
France

131

Institut Claudius Regaud - Oncopole

1 avenue Irène Joliot-Curie
31059 Toulouse
France

132

CHU Nice - Hopital de l Archet

151 route Saint Antoine Ginestiere
06202 Nice
France

133

Hopital Claude Huriez - CHU Lille

Rue Michel Polonovski
59037 Lille
France

134

Centre Hospitalier de Pau - Hôpital François Mitterrand

4 boulevard Hauterive
64046 Pau
France

135

CHU Tours - Hôpital Trousseau

Avenue de la République
37170 Chambray les tours
France

136

Hôpital Saint-Louis

1 Avenue Claude Vellefaux
75010 Paris
France

137

CHU Poitiers - Hôpital la Milétrie

2 rue de la Miletrie
86021 Poitiers
France

138

CHU de Dijon - Hôpital du Bocage

2 Boulevard du Marechal de Lattre de Tassigny
21079 Dijon
France

139

CHU de Bordeaux - Hôpital Saint André

1 rue Jean Burguet
33075 Bordeaux
France

140

Hôpital de la Timone

264 rue Saint Pierre
13385 Marseille
France

141

CAC Clermont-Ferrand Centre Jean Perrin

58 Rue Montalembert
63000 Clermont ferrand
France

142

Centre Hospitalier Lyon Sud

165 chemin du Grand Revoyet
69495 Pierre benite
France

143

Fakultni nemocnice Olomouc

I.P.Pavlova 185/6
79900 Olomouc
Czechia

144

Fakultni nemocnice Ostrava

17.listopadu 1790
708 52 Ostrava
Czechia

145

Vseobecna fakultni nemocnice v Praze

U Nemocnice 499/2
128 08 Praha
Czechia

146

Fakultni nemocnice Hradec Kralove

Sokolska 581
500 05 Hradec kralove
Czechia

147

Fakultni nemocnice Kralovske Vinohrady

Srobarova 1150/50
100 34 Praha
Czechia

148

Cross Cancer Institute

11560 University Avenue
Edmonton T6G 1Z2
Canada

149

Sunnybrook Health Sciences Centre

2075 Bayview Avenue
Toronto M4N 3M5
Canada

150

CIUSSS du Centre Ouest de l'lle de Montreal

3755 chemin Cote-Sainte-Catherine
Montreal H3T 1E2
Canada

151

London Health Sciences Centre (LHSC) - Victoria Hospital

800 Commissioners Rd East, E2-600
London N6A 5W9
Canada

152

Princess Margaret Cancer Centre

610 University Avenue,
Toronto M5G 2M9
Canada

153

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Rua Doutor Ovande do Amaral, 201
Curitiba-
81520-060
Brazil

154

A. C. Camargo Cancer Center

Rua Professor Antonio Prudente, 211
Sao paulo-
01509-900
Brazil

155

Instituto de Cancer de Londrina

Rua Lucilla Ballalai
Londrina-
86015-520
Brazil

156

Fundação Doutor Amaral Carvalho

Rua Dona Silvéria, 150
Jau-
17210-120
Brazil

157

Hospital de Clínicas de Porto Alegre

Rua Ramiro Barcelos, 2350
Porto alegre-
90035-903
Brazil

158

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Av. Lauro Gomes, nº 2000 Pesquisa Clínica
Santo andre-
09060-870
Brazil

159

Instituto de Oncologia Saint Gallen

Rua Marechal Deodoro, 1139
Santa cruz do sul-
96810-110
Brazil

160

CEPEN Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina

Rua Menino Deus 63
Florianopolis-
88015-203
Brazil

161

Centro Gaucho Integrado Mae De Deus Center

Rua Costa, 30 - 3 andar
Porto alegre-
90110-270
Brazil

162

Ensino e Terapia de Inovação Clínica AMO-ETICA.

Rua João Gomes, 225
Salvador-
41950-640
Brazil

163

Universitair Ziekenhuis Brussel

Laarbeeklaan 101
1090 Brussel
Belgium

164

CHU de Liège

Avenue de L'Hospital 1
4000 Liege
Belgium

165

UZ Gent

C. Heymanslaan 10
9000 Gent
Belgium

166

Vitaz

Moerlandstraat 1
9100 Sint niklaas
Belgium

167

CHU UCL Namur

Avenue Docteur G. Therasse 1
5530 Yvoir
Belgium

168

Institut Jules Bordet

Rue Meylemeersch 90, 1070 Anderlecht
1070 Anderlecht
Belgium

169

Cliniques Universitaires Saint-Luc

Avenue Hippocrate 10.
1200 Brussels
Belgium

170

ZNA Middelheim

Lindendreef 1
2020 Antwerpen
Belgium

171

ZNA

Lange Bremstraat 70
2170 Merksem
Belgium

172

Landeskrankenhaus - Universitaetsklinikum Graz

Auenbruggerplatz 8
8036 Graz
Austria

173

Ordensklinikum Linz GmbH Elisabethinen

Fadingerstrasse 1
4020 Linz
Austria

174

AKH - Medizinische Universität Wien

18 - 20 Wahringer Gurtel
1090 Vienna
Austria

175

Adelaide Oncology & Haematology

89 Strangways Terrace
North adelaide 5006
Australia

176

Universitätsklinikum St.Pölten-Lilienfeld

Dunant-Platz 1
3100 St polten
Austria

177

Sir Charles Gairdner Hospital

DD Block,
Nedlands 6009
Australia

178

Box Hill Hospital

Level 2, 5 Arnold Street, Eastern Clinical Research Unit
Box hill 3128
Australia

179

Port Macquarie Base Hospital

Wrights Road
Port macquarie 2444
Australia

180

Melanoma Institute Australia

40 Rocklands Road, The Poche Centre
Wollstonecraft 2065
Australia

181

Cairns Hospital

165 The Esplanade
Cairns 4870
Australia

182

Hollywood Private Hospital

Monash Avenue
Nedlands 6009
Australia

183

Austin Health

145 Studley Road
Heidelberg 3084
Australia

184

The Alfred Hospital

Commercial Road
Prahan 3181
Australia

185

Westmead Hospital

Corner of Hawkesbury and Darcy Road
Sydney 2145
Australia

186

Princess Alexandra Hospital

199 Ipswich Road
Woolloongabba 4102
Australia

187

Sanatorio Britanico S.A.

Paraguay 40.
2000 Rosario
Argentina

188

Clinica Adventista Belgrano

Estomba 1710
C1430EGF Ciudad autonoma buenos aires
Argentina

189

Instituto Alexander Fleming

Cramer 1180
C1426ANZ Ciudad autonoma buenos aires
Argentina

190

Centro Oncologico Korben

Ciudad De La Paz 353 5th Floor Of 501
C1426 Caba
Argentina

191

Hospital Aleman

Av. Pueyrredon 1640
C1118AAT Buenos Aires
Argentina

192

Fundacion CIDEA

Paraguay 2035
C1121ABE Ciudad autonoma bs as
Argentina

193

Instituto de Oncologia de Rosario

Cordoba 2457
S2000KZE Rosario
Argentina

Last update at : 09 September 2024

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