Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

PHASE3CompletedINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

October 5, 2020

Study Completion Date

September 16, 2021

Conditions
Malignant Melanoma
Interventions
DRUG

Dabrafenib

Supplied as dabrafenib 50 mg and 75 mg capsules for oral administration

DRUG

Trametinib

Supplied as trametinib 0.5mg, and 2.0mg tablets for oral administration

Trial Locations (100)

9

Novartis Investigative Site, Helsinki

1000

Novartis Investigative Site, Ljubljana

4102

Novartis Investigative Site, Woolloongabba

7623

Novartis Investigative Site, Pécs

10126

Novartis Investigative Site, Torino

11000

Novartis Investigative Site, Prague

12808

Novartis Investigative Site, Prague

13885

Novartis Investigative Site, Marseille

16132

Novartis Investigative Site, Genova

18547

Novartis Investigative Site, Athens

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20520

Novartis Investigative Site, Turku

21034

Novartis Investigative Site, Dijon

24127

Novartis Investigative Site, Bergamo

25030

Novartis Investigative Site, Besançon

31059

Novartis Investigative Site, Toulouse

33075

Novartis Investigative Site, Bordeaux

33100

Novartis Investigative Site, Udine

34295

Novartis Investigative Site, Montpellier

35040

Novartis Investigative Site, Izmir

35062

Novartis Investigative Site, Rennes

35100

Novartis Investigative Site, Padua

38043

Novartis Investigative Site, Grenoble

41124

Novartis Investigative Site, Modena

47014

Novartis Investigative Site, Meldola

50011

Novartis Investigative Site, Antella - Bagno A Ripoli

51092

Novartis Investigative Site, Reims

52621

Novartis Investigative Site, Ramat Gan

54622

Novartis Investigative Site, Thessaloniki

56322

Novartis Investigative Site, Lorient

59037

Novartis Investigative Site, Lille

63003

Novartis Investigative Site, Clermont-Ferrand

69495

Novartis Investigative Site, Pierre-Bénite

75475

Novartis Investigative Site, Paris

80131

Novartis Investigative Site, Napoli

86021

Novartis Investigative Site, Poitiers

87000

Novartis Investigative Site, Limoges

90127

Novartis Investigative Site, Palermo

92104

Novartis Investigative Site, Boulogne-Billancourt

93009

Novartis Investigative Site, Bobigny

94800

Novartis Investigative Site, Villejuif

115478

Novartis Investigative Site, Moscow

143423

Novartis Investigative Site, Moscow Region Istra Village

197758

Novartis Investigative Site, Saint Petersburg

644013

Novartis Investigative Site, Omsk

9112001

Novartis Investigative Site, Jerusalem

20220410

Novartis Investigative Site, Rio de Janeiro

S200KZE

Novartis Investigative Site, Rosario

C1125ABE

Novartis Investigative Site, Buenos Aires

X5004BAL

Novartis Investigative Site, Córdoba

QLD 4870

Novartis Investigative Site, Cairns

90035-003

Novartis Investigative Site, Porto Alegre

01246 000

Novartis Investigative Site, São Paulo

T2N 4N2

Novartis Investigative Site, Calgary

T6G 1Z2

Novartis Investigative Site, Edmonton

L8V 5C2

Novartis Investigative Site, Hamilton

N6A 4L6

Novartis Investigative Site, London

K1H 8L6

Novartis Investigative Site, Ottawa

M4N 3M5

Novartis Investigative Site, Toronto

M5G 1Z6

Novartis Investigative Site, Toronto

H3T 1E2

Novartis Investigative Site, Montreal

G1R 2J6

Novartis Investigative Site, Québec

656 53

Novartis Investigative Site, Brno

180 00

Novartis Investigative Site, Prague

762 75

Novartis Investigative Site, Zlín

500 05

Novartis Investigative Site, Hradec Králové

708 52

Novartis Investigative Site, Ostrava

779 00

Novartis Investigative Site, Olomouc

FIN-33521

Novartis Investigative Site, Tampere

06202

Novartis Investigative Site, Nice

115 27

Novartis Investigative Site, Athens

GR 115 22

Novartis Investigative Site, Athens

H 1122

Novartis Investigative Site, Budapest

H 6725

Novartis Investigative Site, Szeged

00128

Novartis Investigative Site, Roma

00167

Novartis Investigative Site, Roma

060-8543

Novartis Investigative Site, Sapporo

104 0045

Novartis Investigative Site, Chuo Ku

LV 1079

Novartis Investigative Site, Riga

LT-08660

Novartis Investigative Site, Vilnius

NO-6026

Novartis Investigative Site, Ålesund

0379

Novartis Investigative Site, Oslo

80 952

Novartis Investigative Site, Gdansk

02 781

Novartis Investigative Site, Warsaw

53 413

Novartis Investigative Site, Wroclaw

4200-072

Novartis Investigative Site, Porto

812 50

Novartis Investigative Site, Bratislava

04191

Novartis Investigative Site, Košice

SE-413 45

Novartis Investigative Site, Gothenburg

701 85

Novartis Investigative Site, Örebro

SE 171 76

Novartis Investigative Site, Stockholm

SE 901 85

Novartis Investigative Site, Umeå

BS2 8ED

Novartis Investigative Site, Bristol

HA6 2RN

Novartis Investigative Site, Northwood

S10 2JF

Novartis Investigative Site, Sheffield

CB2 2QQ

Novartis Investigative Site, Cambridge

LS9 7TF

Novartis Investigative Site, Leeds

M20 4BX

Novartis Investigative Site, Manchester

SO16 6YD

Novartis Investigative Site, Southampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY