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Brief Title: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma
Official Title: A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma
Study ID: NCT03273153
Brief Summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC Norris Cancer Center, Los Angeles, California, United States
USC Norris Cancer Center; USC Oncology Hematology Newport Beach, Newport Beach, California, United States
University of California at Irvine Medical Center; Department of Oncology, Orange, California, United States
Stanford Comprehensive Cancer Center, Stanford, California, United States
UF Health Cancer Center at Orlando Health, Orlando, Florida, United States
Florida Cancer Specialist, North Region, Saint Petersburg, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Northwestern University, Chicago, Illinois, United States
Massachusetts General Hospital;Hematology/ Oncology, Boston, Massachusetts, United States
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR), Ann Arbor, Michigan, United States
Dartmouth-Hitchcock Medical Center; Hematology/Oncology, Lebanon, New Hampshire, United States
Morristown Medical Center, Morristown, New Jersey, United States
Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
TriHealth Hatton Institute; Surgical Education, Cincinnati, Ohio, United States
St. Luke's University Health network, Bethlehem, Pennsylvania, United States
Thomas Jefferson University Hospital;Medical Oncology, Philadelphia, Pennsylvania, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
M.D Anderson Cancer Center; Uni of Texas At Houston, Houston, Texas, United States
West Virginia University Hospitals Inc, Morgantown, West Virginia, United States
Cairns Base Hospital, Cairns, Queensland, Australia
Townsville General Hospital, Douglas, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro, RJ, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hopital Avicenne; Dermatologie, Bobigny, , France
Hopital Saint Andre CHU De Bordeaux; Dermatologie, Bordeaux, , France
Chu Site Du Bocage;Dermatologie, Dijon, , France
CHU de Grenoble - Hôpital Nord, Grenoble, , France
Centre Hospitalier Le Mans; Dermatologie, Le Mans, , France
Hopital Claude Huriez; Sce Dermatologie, Lille, , France
Hopital Timone Adultes; Dermatologie, Marseille, , France
CHU de Nantes; Cancéro-dermatologie, Nantes, , France
Hopital l Archet 2; Ginestriere, Service de; Dermatologie, Nice cedex 3, , France
Groupe Hospitalier Bichat Claude Bernard, Paris, , France
Hopital Saint Louis; Dermatologie 1, Paris, , France
Hopital Robert Debre; DERMATOLOGIE, Reims, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
Hopital Charles Nicolle; Dermatologie Serv., Rouen, , France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O), Toulouse, , France
Institut Gustave Roussy; Dermatologie, Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie, Dresden, , Germany
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie, Erfurt, , Germany
Universitatsklinikum Essen; Klinik für Dermatologie, Essen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie, Frankfurt, , Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie, Gera, , Germany
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie, Hannover, , Germany
UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie, Kiel, , Germany
Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie, Mainz, , Germany
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie, Mannheim, , Germany
Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin, Minden, , Germany
Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie, München, , Germany
Fachklinik Hornheide; Dermatologie, Münster, , Germany
Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen, Tübingen, , Germany
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine, Athens, , Greece
Laiko General Hospital Athen, Athens, , Greece
Metropolitan Hospital; Dept. of Oncology, Pireaus, , Greece
Bioclinic Thessaloniki, Thessaloniki, , Greece
Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly, Budapest, , Hungary
Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika, Pecs, , Hungary
University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology, Szeged, , Hungary
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica, Napoli, Campania, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B, Napoli, Campania, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia, Modena, Emilia-Romagna, 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
A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana, Bari, Puglia, Italy
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico, Pisa, Toscana, Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, Veneto, 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
Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde, Amsterdam, , Netherlands
Amphia Ziekenhuis, locatie Langendijk;Oncology, Breda, , Netherlands
Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie, Rotterdam, , Netherlands
Zuyderland ziekenhuis locatie Geleen, Sittard-Geleen, , Netherlands
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu., Poznań, , Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, , Poland
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii, Wrocław, , Poland
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, , Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint-Petersburg, , Russian Federation
St. Petersburg Oncology Hospital, St Petersburg, , Russian Federation
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Hospital Universitario Son Espases; Servicio de Oncologia, Palma De Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia, Las Palmas de Gran Canaria, LAS Palmas, Spain
Clinica Universitaria de Navarra; Servicio de oncología, Pamplona, Navarra, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department, Bristol, , United Kingdom
Western General Hospital; Edinburgh Cancer Center, Edinburgh, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester, , United Kingdom
University College London Hospital, London, , United Kingdom
Guys & St Thomas Hospital; Department of Oncology, London, , United Kingdom
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital, Stoke-On-Trent, , United Kingdom
Singleton Hospital; Pharmacy, Swansea, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_CHAIR