A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

September 24, 2012

Primary Completion Date

June 23, 2017

Study Completion Date

July 13, 2018

Conditions
Melanoma
Interventions
DRUG

Vemurafenib

4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.

DRUG

Placebo

Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.

Trial Locations (207)

7

Mater Private Hospital, Dublin

The Mater Misericordiae Hospital, Dublin

1000

Institut Jules Bordet, Brussels

1011

CHUV; Departement d'Oncologie, Lausanne

1030

Krankenanstalt Rudolfstiftung Wien, Vienna

1090

Medizinische Universität Wien, Vienna

1426

Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma Buenos Aires

2020

ZNA Middelheim, Antwerp

2050

Chris O'Brien Lifehouse, Camperdown

2060

Melanoma Institute Australia, North Sydney

2196

Sandton Oncology Medical Group, Sandton

2298

Calvary Mater Newcastle, Waratah

2500

Southern Medical Day Care Centre, Wollongong

2650

UZ Antwerpen, Edegem

3000

Peter Maccallum Cancer Centre, Melbourne

3004

Alfred Hospital, Melbourne

3128

Box Hill Hospital, Box Hill

3199

Peninsula Oncology Centre; Frankston Private, Frankston

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

3690

Border Medical Oncology, Wodonga

4011

Stavanger Universitetssykehus, Helse Stavanger HF, Stavanger

4600

Klinikum Wels-Grieskirchen, Wels

4812

The Townsville Hospital; Townsville Cancer Centre, Townsville

4870

Cairns Base Hospital, Cairns

5000

Royal Adelaide Hospital; Hepatology, Adelaide

5011

Queen Elizabeth Hospital, Woodville

6012

Wellington Hospital, Wellington

6020

Medizinische Universität Innsbruck, Innsbruck

6150

Fiona Stanley Hospital, Murdoch

7250

Launceston General Hospital; Gastroenterology Research, Launceston

7700

GVI Rondebosch Oncology Centre, Cape Town

7925

Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology, Observatory

8011

Christchurch Hospital NZ, Christchurch

8500

AZ Groeninge, Apotheek, Kortrijk

9000

UZ Gent, Ghent

10000

Clinical Hospital Center Sestre Milosrdnice, Zagreb

Clinical Hospital Centre Zagreb, Zagreb

10016

New York University Medical Center PRIME; NYU Clinical Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

11000

Institute of Oncology and Radiology of Serbia, Belgrade

11040

Military Medical Academy, Belgrade

11070

Clinical Center Bezanijska Kosa, Belgrade

11312

East Tallinn Central Hospital; Clinic of Internal Medicine, Tallinn

13005

Hopital de la Timone, Marseille

13419

North Estonia Medical Centre Foundation, Tallinn

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

16132

Istituto Nazionale per la Ricerca sul Cancro di Genova, Genoa

19104

University of Pennsylvania Health System, Philadelphia

20089

IRCCS Istituto Clinico Humanitas; Farmacia, Rozzano

20132

Ospedale San Raffaele, Milan

20141

Istituto Europeo Di Oncologia, Milan

21204

Institute for oncology of Vojvodina, Kamenitz

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

25030

CHU Besançon - Hôpital Jean Minjoz, Besançon

25100

Asst Degli Spedali Civili Di Brescia, Brescia

26506

Mary Babb Randolph Cancer Center, Morgantown

27710

Duke University Medical Center; Oncology, Durham

28007

Hospital General Universitario Gregorio Marañon, Madrid

29425

MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders, Charleston

29600

Hospital Costa del Sol; Servicio de Oncologia, Marbella

31059

CHU de Toulouse - Hôpital Larrey, Toulouse

33021

Memorial Healthcare System, Hollywood

33075

Groupe Hospitalier Saint André - Hôpital Saint André, Bordeaux

33901

Florida Cancer Specialists - Broadway, Fort Myers

34232

GulfCoast Oncology, Sarasota

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

35294

University of Alabama at Birmingham, Birmingham

37203

Tennessee Oncology PLLC - Nashville (20th Ave), Nashville

37232

Vanderbilt University Medical Center, Nashville

38138

West Clinic, Germantown

40202

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

42000

General Hospital Varazdin, Varaždin

44093

CHU NANTES - Hôtel Dieu; Pharmacy, Nantes

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44791

St. Josef-Hospital Universitaetsklinikum, Bochum

45147

Universitätsklinikum Essen, Essen

46026

Hospital Universitari i Politecnic La Fe, Valencia

46202

Indiana University Department of Medicine; Division of Infectious Diseases, Indianapolis

46526

Indiana University Health; Goshen Center for Cancer Care, Goshen

48157

Fachklinik Hornheide, Münster

48201

Barbara Ann Karmanos Cancer Institute, Detroit

49102

CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

50406

Tartu University Hospital; Clinic of Hematology and Oncology, Tartu

50937

Universitätsklinikum Koeln, Cologne

52100

General Hospital Pula, Pula

53100

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

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke, Mainz

58260

Sanatorio la Luz, Morelia

59037

Hopital Claude Huriez - CHU Lille, Lille

60068

Oncology Specialists, S.C., Park Ridge

60528

Universitaetsklinikum Frankfurt, Frankfurt

62290

Centro Oncologico Belenus, Cuernavaca

63110

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

64111

St. Luke's Hospital, Kansas City

64131

University of Kansas Medical Center; Cancer Center, Kansas City

64710

Centro Regiomontano de Investigación Clínica, Monterrey

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

75475

Hôpital Saint-Louis, Paris

76031

CHU de Rouen Hopital; Service de Neurologie, Rouen

77030

MD Anderson Cancer Center, Houston

79031

Lviv State Oncological Regional Treatment and Diagnostic Center, Lviv

80045

University Of Colorado, Aurora

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

81501

St. Mary's Hospital Regional Cancer Center, Grand Junction

90025

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

90095

UCLA Department of Medicine; Division of Hematology / Oncology, California City

Cancer Center Of Santa Barbara; Network Clinical Research Specialist, Los Angeles

TRIO-US Network Administration; Network Clinical Research Specialist, Los Angeles

91105

UCLA Healthcare/Pasadena Oncology, Pasadena

91355

UCLA Cancer Center Hema/Oncol, Valencia

91361

UCLA Hematology Oncology - Westlake, Westlake Village

92093

UCSD Moores Cancer Center, La Jolla

92104

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

92604

UCLA Hematology Oncology - Irvine, Irvine

93401

Coastal Integrative Cancer Care, San Luis Obispo

94080

Kaiser Permanente - South San Francisco, South San Francisco

94115

Kaiser Permanente, San Francisco

94305

Stanford University School of Medicine; Stanford Hospital Pharmacy, Stanford

94545

Kaiser Permanente - Hayward, Hayward

94589

Kaiser Permanente - Vallejo, Vallejo

94596

Kaiser Permanente - Walnut Creek, Walnut Creek

94611

Kaiser Foundation Hospital - Oakland (W. MacArthur), Oakland

Kaiser Permanente - Oakland, Oakland

95051

Kaiser Permanente - Santa Clara, Santa Clara

95119

K. Permanente - San Jose, San Jose

95661

Kaiser Permanente - Roseville, Roseville

95814

Kaiser Permanente Sacramento Medical Center, Sacramento

97080

Universitätsklinikum Wurzburg, Würzburg

115478

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

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

197758

Scientific Research Oncology Institute named after N.N. Petrov, Saint Petersburg

350040

Krasnodar City Oncology Center, Krasnodar

3109600

Rambam Health Care Campus, Haifa

4941492

Rabin Medical Center-Beilinson Campus, Petah Tikva

5265601

Chaim Sheba Medical Center, Ramat Gan

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

8410101

Soroka Medical Center, Beersheba

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

07869

Atlantic Health Systems; Pediatrics, Randolph Township

C1425DTG

Fundación CIDEA, Buenos Aires

C1284AEB

Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires

B1629ODT

Hospital Universitario Austral, Derqui-Pilar

B2700CPM

Centro de Investigacion Pergamino SA, Pergamino

S2000KZE

Instituto de Oncología de Rosario, Rosario

S3000

ISIS Clinica Especializada, Santa Fe

30150-281

Trymed Clinical Research, Belo Horizonte

99010-260

CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo, Passo Fundo

90035-003

Hospital das Clinicas - UFRGS, Porto Alegre

90430-090

Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre

98700-000

Hospital de Caridade de Ijuí, Ijuí

01308-050

Hospital Sírio-Libanês, São Paulo

V5Z 4E6

BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency, Vancouver

R2H 2A6

Saint Boniface General Hospital; Section of Nephrology BG 007, Winnipeg

E2L 4L2

Saint John Regional Hospital; Department of Oncology, Saint John

N6A 4G5

LHSC - Victoria Hospital; Department of Pediatrics, London

K1H 1C4

The Ottawa Hospital Cancer Center; General Campus, Ottawa

M4N3M50

Toronto Sunnybrook Hospital, Toronto

M5G 2M9

Princess Margaret Hospital; Department of Med Oncology, Toronto

H2L 4M1

CHUM Hôpital Notre-Dame, Montreal

H3A 1A1

Mcgill University - Royal Victoria Hospital; Oncology, Montreal

G1V 4G2

CHUQ - Hôtel-Dieu de Québec, Ste-Foy

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

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna fakultni nemocnice v Praze, Prague

180 01

Nemocnice Na Bulovce, Prague

06202

CHU Nice - Hopital de l'Archet 2, Nice

Unknown

Cork University Hospital, Cork

University College Hospital, Galway

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

00144

Istituto Nazionale Tumori Regina Elena IRCCS, Rome

00167

IDI-Istituto Dermopatico dell'Immacolata IRCCS, Rome

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

2333 ZA

Leids Universitair Medisch Centrum; Cardiology, Leiden

10-228

SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie, Olsztyn

60-693

Przychodnia Med-Polonia Sp. z o.o., Poznan

02-781

Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie, Warsaw

53-439

Dolnoslaskie Centrum Onkologii, Wroclaw

3000-075

IPO de Coimbra; Servico de Oncologia Medica, Coimbra

7000-811

Hospital do Espirito Santo; Servico de Oncologia Medica, Evora

1649-035

Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

0181

Mary Potter Oncology Centre, Groenkloof

0001

University of Pretoria Oncology Department, Pretoria

08025

Hospital de la Santa Creu; i Sant Pau, Barcelona

08908

Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona

551 85

Länssjukhuset Ryhov, Jönköping

901 850

Norrlands Universitetssjukhus, Umeå

351 85

Centrallasarettet Växjö, Vaxjo

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

PE30 4ET

Queen Elizabeth Hospital, Kings Lynn

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

NG5 1PB

Nottingham University Hospitals City Campus, Nottingham

OX3 7LJ

Churchill Hospital, Oxford

TR1 3LQ

Royal Cornwall Hospital, Truro

WV10 0QP

New Cross Hospital, Wolverhampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01667419 - A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma | Biotech Hunter | Biotech Hunter