A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

January 13, 2017

Primary Completion Date

October 11, 2019

Study Completion Date

July 1, 2024

Conditions
Melanoma
Interventions
DRUG

Atezolizumab

Will be administered as per the schedule described in individual arm.

DRUG

Atezolizumab Placebo

Will be administered as per the schedule described in individual arm.

DRUG

Cobimetinib

Will be administered as per the schedule described in individual arm.

DRUG

Vemurafenib

Will be administered as per the schedule described in individual arm.

DRUG

Vemurafenib Placebo

Will be administered as per the schedule described in individual arm.

Trial Locations (110)

1090

Medizinische Universität Wien, Vienna

1122

Orszagos Onkologiai Intezet, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

2610

Sint Augustinus Wilrijk, Wilrijk

3000

Peter Maccallum Cancer Centre, Melbourne

UZ Leuven Gasthuisberg, Leuven

3112

Tauranga Hospital, Clinical Trials Unit, Tauranga

4000

CHU Sart-Tilman, Liège

4102

Princess Alexandra Hospital, Woolloongabba

4442

Mid Central DHB, Palmerston North

5000

Royal Adelaide Hospital, Adelaide

6020

LKH Innsbruck, Innsbruck

6021

Wellington Hospital, Newtown, Wellington

6150

Fiona Stanley Hospital, Murdoch

6720

University of Szeged Szent-Györgyi Albert Clinical Center, Szeged

8030

Medical University of Graz, Department of Dermatology, Graz

10060

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo, Candiolo

10117

Charite - Universitätsmedizin Berlin, Berlin

12000

Sharett Institute - Hadassah Hebrew University Medical Center, Jerusalem

16132

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST), Genoa

18015

St. Luke's University Health network, Bethlehem

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20141

Irccs Istituto Europeo Di Oncologia (IEO), Milan

21616

Elbekliniken Buxtehude, Buxtehude

23538

UKSH Universitatsklinikum Schleswig-Holstein, Lübeck

24105

UKSH Kiel, Kiel

28034

Hospital Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

30625

Medizinische Hochschule Hannover, Hanover

31008

Clinica Universitaria de Navarra, Pamplona

32806

UF Health Cancer Center at Orlando Health, Orlando

33075

Groupe Hospitalier Saint André - Hôpital Saint André, Bordeaux

33100

A.O. Universitaria S. Maria Della Misericordia Di Udine, Udine

33140

Mount Sinai Medical Center, Miami Beach

35042

Centre Eugene Marquis, Rennes

37075

Universitätsmedizin Göttingen, Göttingen

38043

Centre Hospitalier Universitaire de Grenoble - Albert Michallon, Grenoble

41071

Hospital Universitario Virgen de la Macarena, Seville

44093

CHU de Nantes, Nantes

45147

Universitatsklinikum Essen, Essen

46014

Hospital General Universitario de Valencia, Valencia

47014

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola

48157

Fachklinik Hornheide, Münster

50009

Hospital Universitario Miguel Servet, Zaragoza

50937

Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie, Cologne

51092

Hopital Robert Debre, Reims

53100

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

55131

Universitatsklinikum Mainz, Mainz

59037

Hopital Claude Huriez - CHU Lille, Lille

69120

Universitatsklinik Heidelberg, Heidelberg

70124

Istituto Tumori ?Giovanni Paolo II?, Oncologia, Bari

72076

Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen, Tübingen

72762

Highlands Oncology Group, Springdale

76031

CHU de Rouen - Hôpital Charles Nicolle, Rouen

80131

IRCCS Istituto Nazionale Tumori Fondazione Pascale, Napoli

80337

Klinikum der Ludwigs-Maximilians-Universität München, München

85284

Arizona Oncology Associates, PC - HAL, Tempe

92868

UC Irvine Medical Center, Orange

93053

Universitätsklinikum Regensburg, Regensburg

97080

Universitätsklinikum Würzburg, Würzburg

99089

HELIOS Klinikum Erfurt, Erfurt

115478

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

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

3109601

Rambam Health Care Campus, Haifa

4941492

Rabin MC, Petah Tikva

5265601

Ella Institute - Sheba Medical Center, Ramat Gan

35294-3300

University of Alabama at Birmingham, Birmingham

90035-003

Hospital das Clinicas - UFRGS, Porto Alegre

88020-210

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN, Florianópolis

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

22290-160

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

01321-00

Beneficencia Portuguesa de Sao Paulo, São Paulo

T2N 4N2

Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary

R3E 0V9

Cancer Care Manitoba, Winnipeg

L8V 5C2

Juravinski Cancer Clinic, Hamilton

N6A 4L6

LHSC - Victoria Hospital, London

L1G 2B9

Lakeridge Health Oshawa, Oshawa

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4X 1K9

Princess Margaret Hospital, Toronto

G1J 1Z4

CHU de Quebec - Hopital de l'Enfant-Jesus, Québec

04103

Universitätsklinikum Leipzig, Leipzig

06484

Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg, Quedlinburg

115 27

Laiko General Hospital Athen, Athens

185 47

Metropolitan Hospital, Pireaus

00168

IFO - Istituto Regina Elena, Rome

3075 EA

Erasmus Mc - Daniel Den Hoed Kliniek, Rotterdam

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

31-115

Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków, Krakow

20-090

COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin

60-355

Uniwersytecki Szpital Kliniczny w Poznaniu, Późna

02-781

Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy, Warsaw

53-413

Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii, Wroclaw

1099-023

IPO de Lisboa, Lisbon

4200-072

IPO do Porto, Porto

DUMMY_VALUE

"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial, Barcelona

04600

Fundacion Instituto Valenciano de Oncologia (IVO), Valencia

BS2 8ED

Bristol Haematology and Oncology centre, Bristol

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

IP4 5PD

Ipswich Hospital, Ipswich

LS9 7TF

St James Uni Hospital, Leeds

SE1 9RT

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

NE7 7DN

Freeman Hospital, New Castle Upon Tyne

SA2 8QA

Singleton Hospital, Swansea

TR1 3LJ

Royal Cornwall Hospital, Truro

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02908672 - A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma | Biotech Hunter | Biotech Hunter