A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

PHASE3TerminatedINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

February 17, 2017

Primary Completion Date

August 11, 2020

Study Completion Date

August 21, 2024

Conditions
Melanoma
Interventions
BIOLOGICAL

Spartalizumab

Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks

OTHER

Placebo

Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks

DRUG

Dabrafenib

Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.

DRUG

Trametinib

Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions

Trial Locations (179)

1090

Novartis Investigative Site, Brussels

1200

Novartis Investigative Site, Brussels

1303

Novartis Investigative Site, Sofia

2060

Novartis Investigative Site, North Sydney

2290

Novartis Investigative Site, Gateshead

2333

Novartis Investigative Site, Leiden

3004

Novartis Investigative Site, Melbourne

3100

Novartis Investigative Site, Sankt Pölten

4004

Novartis Investigative Site, Plovdiv

4020

Novartis Investigative Site, Linz

4032

Novartis Investigative Site, Debrecen

4120

Novartis Investigative Site, Greenslopes

5001

Novartis Investigative Site, Aarau

6009

Novartis Investigative Site, Nedlands

6020

Novartis Investigative Site, Innsbruck

8036

Novartis Investigative Site, Graz

8091

Novartis Investigative Site, Zurich

8200

Novartis Investigative Site, Aarhus N

10016

NYU Laura and Isaac Perlmutter Cancer Center, New York

10060

Novartis Investigative Site, Candiolo

10126

Novartis Investigative Site, Torino

10330

Novartis Investigative Site, Bangkok

11407

Novartis Investigative Site, Jerez de la Frontera

12808

Novartis Investigative Site, Prague

13353

Novartis Investigative Site, Berlin

13578

Novartis Investigative Site, Berlin

13885

Novartis Investigative Site, Marseille

14033

Novartis Investigative Site, Caen

14080

Novartis Investigative Site, Mexico City

15006

Novartis Investigative Site, A Coruña

15213

University of Pittsburgh Med Center, Pittsburgh

16132

Novartis Investigative Site, Genova

18547

Novartis Investigative Site, Athens

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

20900

Novartis Investigative Site, Monza

21034

Novartis Investigative Site, Dijon

21093

Johns Hopkins U, Lutherville

21682

Novartis Investigative Site, Stade

24105

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

25030

Novartis Investigative Site, Besançon

25123

Novartis Investigative Site, Brescia

28009

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

32429

Novartis Investigative Site, Minden

33011

Novartis Investigative Site, Oviedo

33075

Novartis Investigative Site, Bordeaux

35016

Novartis Investigative Site, Las Palmas de Gran Canaria

35039

Novartis Investigative Site, Marburg

35100

Novartis Investigative Site, Padua

37134

Novartis Investigative Site, Verona

37178

Novartis Investigative Site, León

37920

University of Tennessee Medical Ctr, Knoxville

38043

Novartis Investigative Site, Grenoble

40138

Novartis Investigative Site, Bologna

40225

Novartis Investigative Site, Düsseldorf

41009

Novartis Investigative Site, Seville

41124

Novartis Investigative Site, Modena

44100

Novartis Investigative Site, Guadalajara

45147

Novartis Investigative Site, Essen

46014

Novartis Investigative Site, Valencia

47014

Novartis Investigative Site, Meldola

48157

Novartis Investigative Site, Münster

51092

Novartis Investigative Site, Reims

53100

Novartis Investigative Site, Siena

53105

Novartis Investigative Site, Bonn

54519

Novartis Investigative Site, Vandœuvre-lès-Nancy

55131

Novartis Investigative Site, Mainz

56322

Novartis Investigative Site, Lorient

59037

Novartis Investigative Site, Lille

63003

Novartis Investigative Site, Clermont-Ferrand

66205

University of Kansas Cancer Center, Westwood

66421

Novartis Investigative Site, Homburg

67091

Novartis Investigative Site, Strasbourg

68070

Novartis Investigative Site, Mulhouse

68130

Nebraska Cancer Specialists, Omaha

68305

Novartis Investigative Site, Mannheim

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Bénite

70124

Novartis Investigative Site, Bari

72000

Novartis Investigative Site, Le Mans

72076

Novartis Investigative Site, Tübingen

75475

Novartis Investigative Site, Paris

76031

Novartis Investigative Site, Rouen

77030

Univ of TX MD Anderson Cancer Cntr, Houston

79106

Novartis Investigative Site, Freiburg im Breisgau

80054

Novartis Investigative Site, Amiens

80131

Novartis Investigative Site, Napoli

81377

Novartis Investigative Site, München

84106

Utah Cancer Specialists, Salt Lake City

86021

Novartis Investigative Site, Poitiers

87000

Novartis Investigative Site, Limoges

90110

Novartis Investigative Site, Songkhla

92024

California Cancer Associates for Research and Excellence, Encinitas

92104

Novartis Investigative Site, Boulogne-Billancourt

93009

Novartis Investigative Site, Bobigny

93053

Novartis Investigative Site, Regensburg

94115

California Pacific Medical Center, San Francisco

94305

Stanford Cancer Center, Stanford

94800

Novartis Investigative Site, Villejuif

99089

Novartis Investigative Site, Erfurt

115478

Novartis Investigative Site, Moscow

143423

Novartis Investigative Site, Moscow

197758

Novartis Investigative Site, Saint Petersburg

198255

Novartis Investigative Site, Saint Petersburg

443011

Novartis Investigative Site, Samara

454048

Novartis Investigative Site, Chelyabinsk

603137

Novartis Investigative Site, Nizhny Novgorod

644013

Novartis Investigative Site, Omsk

3109601

Novartis Investigative Site, Haifa

4810469

Novartis Investigative Site, Temuco

5265601

Novartis Investigative Site, Ramat Gan

7500921

Novartis Investigative Site, Santiago

8420383

Novartis Investigative Site, Santiago

9112001

Novartis Investigative Site, Jerusalem

92613-4091

UC Irvine Medical Center, Orange

C1125ABD

Novartis Investigative Site, CABA

C1426ANZ

Novartis Investigative Site, CABA

S2000KZE

Novartis Investigative Site, Rosario

C1431FWO

Novartis Investigative Site, Caba

A-5020

Novartis Investigative Site, Salzburg

80530 010

Novartis Investigative Site, Curitiba

90035-003

Novartis Investigative Site, Porto Alegre

01246 000

Novartis Investigative Site, São Paulo

20560-120

Novartis Investigative Site, Rio de Janeiro

V5Z 4E6

Novartis Investigative Site, Vancouver

M4N 3M5

Novartis Investigative Site, Toronto

H3T 1E2

Novartis Investigative Site, Montreal

H4A 3J1

Novartis Investigative Site, Montreal

J1H 5N4

Novartis Investigative Site, Sherbrooke

656 53

Novartis Investigative Site, Brno

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

100 34

Novartis Investigative Site, Prague

06202

Novartis Investigative Site, Nice

04103

Novartis Investigative Site, Leipzig

06120

Novartis Investigative Site, Halle

09117

Novartis Investigative Site, Chemnitz

01307

Novartis Investigative Site, Dresden

07548

Novartis Investigative Site, Gera

115 27

Novartis Investigative Site, Athens

H 1122

Novartis Investigative Site, Budapest

H 6725

Novartis Investigative Site, Szeged

00167

Novartis Investigative Site, Roma

812-8582

Kyushu University Hospital, Fukuoka

606 8507

Kyoto University Hospital, Sakyo Ku

541-8567

Osaka International Cancer Institute, Osaka

113-8677

Tokyo Metropolitan Komagome Hospital, Bunkyo Ku

104 0045

National Cancer Hospital, Chuo Ku

3818 ES

Novartis Investigative Site, Amersfroort

0310

Novartis Investigative Site, Oslo

80 952

Novartis Investigative Site, Gdansk

02 781

Novartis Investigative Site, Warsaw

1099 023

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

08916

Novartis Investigative Site, Badalona

08036

Novartis Investigative Site, Barcelona

SE-413 45

Novartis Investigative Site, Gothenburg

221 85

Novartis Investigative Site, Lund

SE 171 76

Novartis Investigative Site, Stockholm

TR1 3LJ

Novartis Investigative Site, Truro

GU2 7XX

Novartis Investigative Site, Guildford

SM2 5PT

Novartis Investigative Site, Sutton

LE1 5WW

Novartis Investigative Site, Leicester

NW3 2QG

Novartis Investigative Site, London

M20 2BX

Novartis Investigative Site, Manchester

TS4 3BW

Novartis Investigative Site, Middlesbrough

PR2 9HT

Novartis Investigative Site, Preston

WD187HT

Novartis Investigative Site, Rickmansworth Road

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY