Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

704

Participants

Timeline

Start Date

June 4, 2012

Primary Completion Date

April 17, 2014

Study Completion Date

April 25, 2019

Conditions
Melanoma
Interventions
DRUG

Dabrafenib

Dabrafenib 150 mg twice daily orally

DRUG

Vemurafenib

Vemurafenib 960 mg twice daily orally

DRUG

Trametinib

Trametinib 2 mg once daily orally

Trial Locations (205)

4

Novartis Investigative Site, Dublin

7

Novartis Investigative Site, Dublin

9

Novartis Investigative Site, Dublin

100

Novartis Investigative Site, Taipei

333

Novartis Investigative Site, Taoyuan District

704

Novartis Investigative Site, Tainan City

1011

Novartis Investigative Site, Lausanne

1062

Novartis Investigative Site, Budapest

1090

Novartis Investigative Site, Vienna

Novartis Investigative Site, Brussels

1200

Novartis Investigative Site, Brussels

1478

Novartis Investigative Site, Lorenskog

2060

Novartis Investigative Site, North Sydney

2145

Novartis Investigative Site, Westmead

2610

Novartis Investigative Site, Wilrijk

2730

Novartis Investigative Site, Herlev

2930

Novartis Investigative Site, Brasschaat

3000

Novartis Investigative Site, Santa Fe

Novartis Investigative Site, Leuven

3004

Novartis Investigative Site, Melbourne

3128

Novartis Investigative Site, Box Hill

3526

Novartis Investigative Site, Miskolc

4029

Novartis Investigative Site, Herston

4031

Novartis Investigative Site, Basel

4032

Novartis Investigative Site, Debrecen

4101

Novartis Investigative Site, South Brisbane

4120

Novartis Investigative Site, Greenslopes

4604

Novartis Investigative Site, Kristiansand

5000

Novartis Investigative Site, Namur

5011

Novartis Investigative Site, Woodville

6002

Novartis Investigative Site, Newtown, Wellington

6009

Novartis Investigative Site, Nedlands

6020

Novartis Investigative Site, Innsbruck

6720

Novartis Investigative Site, Szeged

7400

Novartis Investigative Site, Kaposvár

8000

Novartis Investigative Site, Arhus C

8011

Novartis Investigative Site, Christchurch

8091

Novartis Investigative Site, Zurich

8500

Novartis Investigative Site, Kortrijk

9000

Novartis Investigative Site, Ghent

10029

Novartis Investigative Site, New York

13385

Novartis Investigative Site, Marseille

16132

Novartis Investigative Site, Genoa

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20520

Novartis Investigative Site, Turku

21614

Novartis Investigative Site, Buxtehude

22903

Novartis Investigative Site, Charlottesville

23538

Novartis Investigative Site, Lübeck

24105

Novartis Investigative Site, Kiel

24128

Novartis Investigative Site, Bergamo

27710

Novartis Investigative Site, Durham

28007

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

28204

Novartis Investigative Site, Charlotte

29425

Novartis Investigative Site, Charleston

29605

Novartis Investigative Site, Greenville

30322

Novartis Investigative Site, Atlanta

30341

Novartis Investigative Site, Atlanta

30625

Novartis Investigative Site, Hanover

31008

Novartis Investigative Site, Pamplona

32204

Novartis Investigative Site, Jacksonville

32804

Novartis Investigative Site, Orlando

33075

Novartis Investigative Site, Bordeaux

33140

Novartis Investigative Site, Miami Beach

33520

Novartis Investigative Site, Tampere

34295

Novartis Investigative Site, Montpellier

35016

Novartis Investigative Site, Las Palmas de Gran Canaria

35042

Novartis Investigative Site, Rennes

35128

Novartis Investigative Site, Padua

35243

Novartis Investigative Site, Birmingham

37232

Novartis Investigative Site, Nashville

38043

Novartis Investigative Site, Grenoble

39120

Novartis Investigative Site, Magdeburg

40005

Novartis Investigative Site, Sumy

40620

Novartis Investigative Site, Jyväskylä

43210

Novartis Investigative Site, Columbus

44093

Novartis Investigative Site, Nantes

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Novartis Investigative Site, Essen

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Novartis Investigative Site, Cincinnati

46009

Novartis Investigative Site, Valencia

46014

Novartis Investigative Site, Valencia

48109

Novartis Investigative Site, Ann Arbor

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Novartis Investigative Site, Dnipropetrovsk

50937

Novartis Investigative Site, Cologne

51092

Novartis Investigative Site, Reims

52242

Novartis Investigative Site, Iowa City

52621

Novartis Investigative Site, Ramat Gan

53127

Novartis Investigative Site, Bonn

53226

Novartis Investigative Site, Milwaukee

55131

Novartis Investigative Site, Mainz

55432

Novartis Investigative Site, Fridley

56126

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

61070

Novartis Investigative Site, Kharkiv

63110

Novartis Investigative Site, St Louis

67063

Novartis Investigative Site, Ludwigshafen am Rhein

68167

Novartis Investigative Site, Mannheim

69120

Novartis Investigative Site, Heidelberg

72076

Novartis Investigative Site, Tübingen

74078

Novartis Investigative Site, Heilbronn

75246

Novartis Investigative Site, Dallas

75475

Novartis Investigative Site, Paris

76275

Novartis Investigative Site, Zlín

79031

Novartis Investigative Site, Lviv

80010

Novartis Investigative Site, Aurora

80131

Novartis Investigative Site, Napoli

80337

Novartis Investigative Site, Munich

80802

Novartis Investigative Site, Munich

80804

Novartis Investigative Site, Munich

83092

Novartis Investigative Site, Donetsk

84106

Novartis Investigative Site, Salt Lake City

85234

Novartis Investigative Site, Gilbert

88017

Novartis Investigative Site, Uzhhorod

89148

Novartis Investigative Site, Las Vegas

90211

Novartis Investigative Site, Beverly Hills

90419

Novartis Investigative Site, Nuremberg

91054

Novartis Investigative Site, Erlangen

93053

Novartis Investigative Site, Regensburg

94115

Novartis Investigative Site, San Francisco

94589

Novartis Investigative Site, Vallejo

94805

Novartis Investigative Site, Villejuif

97080

Novartis Investigative Site, Würzburg

97213

Novartis Investigative Site, Portland

97239

Novartis Investigative Site, Portland

97701

Novartis Investigative Site, Bend

99089

Novartis Investigative Site, Erfurt

115478

Novartis Investigative Site, Moscow

143423

Novartis Investigative Site, Moscow

197758

Novartis Investigative Site, Saint Petersburg

390011

Novartis Investigative Site, Ryazan

454087

Novartis Investigative Site, Chelyabinsk

455001

Novartis Investigative Site, Magnitogorsk

603081

Novartis Investigative Site, Nizhny Novgorod

07601

Novartis Investigative Site, Hackensack

08901

Novartis Investigative Site, New Brunswick

27599-7600

Novartis Investigative Site, Chapel Hill

84112-5550

Novartis Investigative Site, Salt Lake City

05403

Novartis Investigative Site, Burlington

C1426ANZ

Novartis Investigative Site, Capital Federal

R8500ACE

Novartis Investigative Site, Viedma

S2000KZE

Novartis Investigative Site, Rosario

C1121ABE

Novartis Investigative Site, Buenos Aires

T4000IAK

Novartis Investigative Site, San Miguel de Tucumán

A-8036

Novartis Investigative Site, Graz

A-5020

Novartis Investigative Site, Salzburg

A-1030

Novartis Investigative Site, Vienna

98700-000

Novartis Investigative Site, Ijuí

88301-215

Novartis Investigative Site, Itajaí

01323-900

Novartis Investigative Site, Sao Paulo - SP

T2N 4N2

Novartis Investigative Site, Calgary

V1Y 5L3

Novartis Investigative Site, Kelowna

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Novartis Investigative Site, Vancouver

R3E 0V9

Novartis Investigative Site, Winnipeg

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Novartis Investigative Site, Halifax

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Novartis Investigative Site, Kingston

L1G 2B9

Novartis Investigative Site, Oshawa

K1H 8L6

Novartis Investigative Site, Ottawa

M4N 3M5

Novartis Investigative Site, Toronto

M5G 2M9

Novartis Investigative Site, Toronto

H2L 4M1

Novartis Investigative Site, Montreal

G1R 2J6

Novartis Investigative Site, Québec

775 20

Novartis Investigative Site, Olomouc

708 52

Novartis Investigative Site, Ostrava

100 34

Novartis Investigative Site, Prague

128 08

Novartis Investigative Site, Prague

5000 C

Novartis Investigative Site, Odense

00029

Novartis Investigative Site, Helsinki

06202

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

07548

Novartis Investigative Site, Gera

H-1122

Novartis Investigative Site, Budapest

H-9024

Novartis Investigative Site, Győr

Unknown

Novartis Investigative Site, Co.Cork

Novartis Investigative Site, Galway

Novartis Investigative Site, Jerusalem

00167

Novartis Investigative Site, Rome

1066 CX

Novartis Investigative Site, Amsterdam

1081 HV

Novartis Investigative Site, Amsterdam

9713 GZ

Novartis Investigative Site, Groningen

8934 AD

Novartis Investigative Site, Leeuwarden

2333 ZA

Novartis Investigative Site, Leiden

3015 GD

Novartis Investigative Site, Rotterdam

0310

Novartis Investigative Site, Oslo

80-215

Novartis Investigative Site, Gdansk

62-500

Novartis Investigative Site, Konin

60-693

Novartis Investigative Site, Poznan

02-781

Novartis Investigative Site, Warsaw

410-769

Novartis Investigative Site, Goyang-si, Gyeonggi-Do

03080

Novartis Investigative Site, Seoul

135-710

Novartis Investigative Site, Seoul

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, Hospitalet de Llobregat, Barcelona

07010

Novartis Investigative Site, Palma de Mallorca

SE-581 85

Novartis Investigative Site, Linköping

SE-901 85

Novartis Investigative Site, Umeå

03022

Novartis Investigative Site, Kyiv

CB2 0QQ

Novartis Investigative Site, Cambridge

G12 0YN

Novartis Investigative Site, Glasgow

NW3 2QG

Novartis Investigative Site, London

SE1 7EH

Novartis Investigative Site, London

M20 4BX

Novartis Investigative Site, Manchester

SO16 6YD

Novartis Investigative Site, Southampton

SA2 8QA

Novartis Investigative Site, Swansea

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All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY