Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Study ID: NCT02908672
Conditions
Study Description
Brief Summary: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HAL, Tempe, Arizona, United States
Highlands Oncology Group, Springdale, Arkansas, United States
UC Irvine Medical Center, Orange, California, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
UF Health Cancer Center at Orlando Health, Orlando, Florida, United States
Oncology Specialists, S.C., Park Ridge, Illinois, United States
St. Luke's University Health network, Bethlehem, Pennsylvania, United States
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Medical University of Graz, Department of Dermatology, Graz, , Austria
LKH Innsbruck; Universitätsklinik für Dermatologie, Innsbruck, , Austria
Medizinische Universität Wien; Univ.Klinik für Dermatologie, Wien, , Austria
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Clinicas Oncologicas Integradas - COI, Rio De Janeiro, RJ, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN, Florianopolis, SC, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Beneficencia Portuguesa de Sao Paulo, São Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
Juravinski Cancer Clinic; Department of Oncology, Hamilton, Ontario, Canada
LHSC - Victoria Hospital; London Regional Cancer Program, London, Ontario, Canada
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie, Quebec, , Canada
Groupe Hospitalier Saint André - Hôpital Saint André, Bordeaux, , France
Hopital du Bocage; Dermatologie, Dijon, , France
Centre Hospitalier Universitaire de Grenoble - Albert Michallon, La Tronche, , France
Hopital Claude Huriez - CHU Lille, Lille, , France
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie, Montpellier, , France
CHU de Nantes; Cancéro-dermatologie, Nantes, , France
Hopital Robert Debre; DERMATOLOGIE, Reims, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
CHU de Rouen - Hôpital Charles Nicolle, Rouen, , France
Institut Gustave Roussy; Dermatologie, Villejuif, , France
Charite - Universitätsmedizin Berlin, Berlin, , Germany
Elbekliniken Buxtehude; Klinik für Dermatologie, Buxtehude, , Germany
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie, Erfurt, , Germany
Universitätsklinikum Erlangen; Hautklinik, Erlangen, , Germany
Universitatsklinikum Essen; Klinik für Dermatologie, Essen, , Germany
Universitätsmedizin Göttingen; Klinik für Gastroenterologie, gastrointestinale, Göttingen, , Germany
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie, Hannover, , Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen, Heidelberg, , Germany
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie, Kiel, , Germany
Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie, Köln, , Germany
Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie, Leipzig, , Germany
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d, Lübeck, , Germany
Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie, Mainz, , Germany
Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie, München, , Germany
Fachklinik Hornheide; Dermatologie, Münster, , Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz, Quedlinburg, , Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie, Regensburg, , Germany
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen, Tübingen, , Germany
Universitätsklinikum Würzburg; Med. Klinik 1, Pneumologie, Würzburg, , Germany
Laiko General Hospital Athen, Athens, , Greece
Metropolitan Hospital; Dept. of Oncology, Pireaus, , Greece
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly, Budapest, , Hungary
University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology, Szeged, , Hungary
Rambam Health Care Campus; Oncology, Haifa, , Israel
Sharett Institute - Hadassah Hebrew University Medical Center, Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
Ella Institute - Sheba Medical Center, Ramat-Gan, , Israel
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B, Napoli, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia, Udine, Friuli-Venezia Giulia, Italy
IFO - Istituto Regina Elena; Oncologia Medica, Roma, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genova, Liguria, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milano, Lombardia, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo, Piemonte, Italy
Istituto Tumori ?Giovanni Paolo II?, Oncologia, Bari, Puglia, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte, Siena, Toscana, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie, Rotterdam, , Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service, Auckland, , New Zealand
Wellington Hospital; Wellington Blood and Cancer Centre, Newtown, , New Zealand
Mid Central DHB, Palmerston North, , New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School, Tauranga, , New Zealand
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk, , Poland
Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej, Kraków, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Pozna?, , Poland
Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy, Warszawa, , Poland
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii, Wroc?aw, , Poland
IPO de Lisboa; Servico de Oncologia Medica, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, Moskovskaja Oblast, Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint-Petersburg, Sankt Petersburg, Russian Federation
St. Petersburg Oncology Hospital, Sankt-peterburg, Sankt Petersburg, Russian Federation
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen de la Macarena;, Sevilla, , Spain
Fundacion Instituto Valenciano de Oncologia (IVO), Valencia, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Bristol Haematology and Oncology centre, Bristol, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Ipswich Hospital; Oncology Pharmacy, Ipswich, , United Kingdom
St James Uni Hospital; Icrf Cancer Medicine Research Unit, Leeds, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
Freeman Hospital; Northern Centre For Cancer Care, New Castle Upon Tyne, , United Kingdom
Singleton Hospital; Pharmacy Department, Swansea, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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