A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

495

Participants

Timeline

Start Date

January 8, 2013

Primary Completion Date

May 9, 2014

Study Completion Date

July 21, 2019

Conditions
Malignant Melanoma
Interventions
DRUG

Placebo

Placebo supplied as tablets

DRUG

Vemurafenib

Vemurafenib supplied as tablets

DRUG

Cobimetinib

Cobimetinib supplied as tablets

Trial Locations (156)

1000

Institut Jules Bordet; Department of Medical Oncology, Brussels

1023

Auckland City Hospital, Auckland

1090

Medizinische Universität Wien, Vienna

1122

Orszagos Onkologiai Intezet, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2050

Chris O'Brien Lifehouse, Camperdown

Princess Alexandra Hospital, Woolloongabba

2060

Melanoma Institute Australia, North Sydney

2290

Lake Macquarie Private Hospital, Gateshead

2480

Lismore Base Hospital; Cancer Care & Haematology Unit, Lismore

2650

UZ Antwerpen, Edegem

2903

Rhode Island Hospital; Investigational Services, Providence

3000

Peter MacCallum Cancer Centre-East Melbourne, Melbourne

3010

Inselspital-Universitaetsspital Bern, Bern

3084

Austin Hospital, Heidelberg

3100

Landesklinikum St. Pölten, Sankt Pölten

3181

The Alfred Hospital, Prahan

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

3248

Waikato Hospital, Hamilton

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

4000

CHU Sart-Tilman, Liège

4020

Ordensklinikum Linz Elisabethinen, Linz

4029

Royal Brisbane and Women's Hospital, Herston

4120

Greenslopes Private Hospital, Greenslopes

5000

Royal Adelaide Hospital; Hepatology, Adelaide

5035

Ashford Cancer Centre, Ashford SA

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula

6150

Fiona Stanley Hospital, Murdoch

6720

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp., Szeged

7000

Royal Hobart Hospital, Hobart

Kantonsspital Graubuenden, Chur

7250

Launceston General Hospital; Gastroenterology Research, Launceston

7624

Somogy Megyei Kaposi Mor Oktato Korhaz, Pécs

8800

AZ Delta (Campus Rumbeke), Roeselare

13005

Hopital de la Timone, Marseille

15261

University of Pittsburgh, Pittsburgh

15706

Complexo Hospitalario Universitario de Santiago, Santiago de Compostela

16132

Istituto Nazionale per la Ricerca sul Cancro di Genova, Genoa

18015

St. Luke's University Health network, Bethlehem

19107

Thomas Jefferson University Hospital, Philadelphia

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

21000

CHU de Dijon - Hopital le Bocage, Dijon

21614

Elbekliniken Buxtehude GmbH, Buxtehude

24105

Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin, Kiel

24127

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

25100

Asst Degli Spedali Civili Di Brescia, Brescia

27103

Novant Health Oncology Specialists, Winston-Salem

28033

MD Anderson Cancer Center, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30625

Medizinische Hochschule Hannover, Hanover

31008

Clinica Universitaria de Navarra, Pamplona

32806

Orlando Health Inc., Orlando

33075

Groupe Hospitalier Saint André - Hôpital Saint André, Bordeaux

33140

Mount Sinai Medical Center, Miami Beach

33901

Florida Cancer Specialists - Broadway, Fort Myers

34295

Hopital Saint Eloi, Montpellier

35042

Centre Eugene Marquis; Service d'oncologie, Rennes

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

35233

University of Alabama at Birmingham, Birmingham

37075

Universitätsmedizin Göttingen, Göttingen

37232

Vanderbilt University Medical Center, Nashville

38700

Centre Hospitalier Universitaire de Grenoble - Albert Michallon, La Tronche

40124

A.O.U. Policlinico di Modena, Modena

40202

U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology, Louisville

41071

Hospital Universitario Virgen Macarena, Seville

44093

CHU NANTES - Hôtel Dieu; Pharmacy, Nantes

44106

University Hospitals of Cleveland, Cleveland

44791

St. Josef-Hospital; Studienambulanz, Bochum

45147

Universitätsklinikum Essen, Essen

46014

Hospital General Universitario de Valencia, Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

48157

Fachklinik Hornheide, Münster

50009

Hospital Universitario Miguel Servet, Zaragoza

50937

Universitaetsklinikum Koeln; Hematology/Oncology, Cologne

51092

Hopital Robert Debre; DERMATOLOGIE, Reims

53100

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

55101

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

59037

Hopital Claude Huriez - CHU Lille, Lille

60611

Northwestern Center For Clinical Research, Chicago

63003

CHU Clermont Ferrand - Hôpital d'Estaing, Clermont-Ferrand

63108

Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology, St Louis

68167

Klinikum Mannheim GmbH Universitätsklinikum, Mannheim

69120

Universitätsklinikum Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70126

Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari, Bari

72076

Universitätsklinikum Tübingen, Tübingen

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80045

University Of Colorado, Aurora

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

80337

Klinikum der Ludwigs-Maximilians-Universitaet Muenchen, München

90025

The Angeles Clinic and Research Institute - W LA Office, Los Angeles

92104

Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory, Boulogne-Billancourt

93053

Universitaetsklinikum Regensburg, Regensburg

95403

Sutter Pacific Medical Foundation, Santa Rosa

95817

University of California Davis Health System, Sacramento

97080

Universitätsklinikum Wurzburg, Würzburg

99089

Helios Klinikum Erfurt, Erfurt

115478

"FSBSI N. N. Blokhin Russian Cancer Research Center", Moscow

143423

Moscow city oncology hospital #62 of Moscow Healthcare Department, Moscow

357524

Pyatigorsky Oncologic Dispensary, Pyatigorsk

644013

BHI of Omsk region Clinical Oncology Dispensary, Omsk

656045

TSBHI Altai Territorial oncological dispensary, Barnaul

3109600

Rambam Health Care Campus, Haifa

4941492

Rabin Medical Center-Beilinson Campus;Hematology-Oncology, Petah Tikva

5265601

Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division, Tel Aviv

8410100

Soroka Medical Center; Oncology Dept, Beersheba

9112000

HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology, Jerusalem

66160-7314

Uni of Kansas Medical Center; Dept of Neurology, Kansas City

03756

Dartmouth-Hitchcock Medical Center; Department of Medicine, Lebanon

0811

Royal Darwin Hospital, Casuarina

V8R 6V5

BC Cancer Agency Vancouver Island Cancer Centre, Victoria

L8V 5C2

Juravinski Cancer Clinic; Department of Oncology, Hamilton

K1H 1C4

The Ottawa Hospital Cancer Center; General Campus, Ottawa

M4N 3M5

Toronto Sunnybrook Hospital, Toronto

M5G 2M9

Princess Margaret Hospital; Department of Med Oncology, Toronto

N6A 4G5

London Health Sciences Centre · Victoria Hospital;Department of Pediatrics, London

H2W 1S6

McGill University Health Centre/Glen Site / Royal Victoria Hospital, Montreal

656 53

Masarykuv onkologicky ustav, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

775 20

Fakultní nemocnice Olomouc, Olomouc

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

532 03

Multiscan s.r.o., Pardubice

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna fakultni nemocnice v Praze, Prague

150 06

Fakultni nemocnice Motol; Neurologicka klinika, Prague

180 01

Nemocnice Na Bulovce, Prague

06202

CHU Nice - Hopital de l'Archet 2, Nice

01307

"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden

07548

SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie, Gera

00144

Istituto Nazionale Tumori Regina Elena IRCCS, Rome

1081 HV

Amsterdam UMC Location VUMC, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum; Cardiology, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

0379

Radiumhospitalet, Oslo

08036

Hospital Clínic i Provincial de Barcelona, Barcelona

551 85

Länssjukhuset Ryhov, Jönköping

221 85

Skånes Universitetssjukhus, Lund

435 33

Sahlgrenska Sjukhuset, Mölnlycke

751 85

Akademiska Sjukhuset, Uppsala

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

CB2 0QQ

Addenbrooke's Hospital, Cambridge

CF14 2TL

Velindre Cancer Centre, Cardiff

EH4 2XU

Western General Hospital, Edinburgh

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

L7 8YA

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

EC1A 7BE

Barts and the London NHS Trust., London

SW17 0QT

St George's Hospital; Courtyard Clinic, London

SW3 6JJ

Royal Marsden Hospital - Fulham, London

Royal Marsden Hospital - London, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

NG7 2UH

Nottingham University Hospitals; QMC Campus, Nottingham

SO16 6YD

Southampton General Hospital, Southampton

TR1 3LQ

Royal Cornwall Hospital, Truro

WV10 0QP

New Cross Hospital, Wolverhampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01689519 - A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma | Biotech Hunter | Biotech Hunter