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Spots Global Cancer Trial Database for A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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