Spots Global Cancer Trial Database for A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
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Trial Identification
Brief Title: A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
Official Title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Study ID: NCT01689519
Conditions
Study Description
Brief Summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.
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
The Angeles Clinic and Research Institute - W LA Office, Los Angeles, California, United States
University of California Davis Health System, Sacramento, California, United States
Sutter Pacific Medical Foundation, Santa Rosa, California, United States
University Of Colorado, Aurora, Colorado, United States
Florida Cancer Specialists - Broadway, Fort Myers, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Orlando Health Inc., Orlando, Florida, United States
Northwestern Center For Clinical Research, Chicago, Illinois, United States
Uni of Kansas Medical Center; Dept of Neurology, Kansas City, Kansas, United States
U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology, Louisville, Kentucky, United States
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology, Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center; Department of Medicine, Lebanon, New Hampshire, United States
Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
St. Luke's University Health network, Bethlehem, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital; Investigational Services, Providence, Rhode Island, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Lake Macquarie Private Hospital, Gateshead, New South Wales, Australia
Lismore Base Hospital; Cancer Care & Haematology Unit, Lismore, New South Wales, Australia
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, New South Wales, Australia
Royal Darwin Hospital, Casuarina, Northern Territory, Australia
Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Royal Adelaide Hospital; Hepatology, Adelaide, South Australia, Australia
Ashford Cancer Centre, Ashford SA, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Launceston General Hospital; Gastroenterology Research, Launceston, Tasmania, Australia
Peninsula and South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre-East Melbourne, Melbourne, Victoria, Australia
The Alfred Hospital, Prahan, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Ordensklinikum Linz Elisabethinen, Linz, , Austria
Landesklinikum St. Pölten, St. Pölten, , Austria
Medizinische Universität Wien, Wien, , Austria
Institut Jules Bordet; Department of Medical Oncology, Bruxelles, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Antwerpen, Edegem, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
CHU Sart-Tilman, Liège, , Belgium
AZ Delta (Campus Rumbeke), Roeselare, , Belgium
BC Cancer Agency Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
Juravinski Cancer Clinic; Department of Oncology, Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Center; General Campus, Ottawa, Ontario, Canada
Toronto Sunnybrook Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital; Department of Med Oncology, Toronto, Ontario, Canada
London Health Sciences Centre · Victoria Hospital;Department of Pediatrics, London, Quebec, Canada
McGill University Health Centre/Glen Site / Royal Victoria Hospital, Montréal, Quebec, Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia
Multiscan s.r.o., Pardubice, , Czechia
Nemocnice Na Bulovce, Prague, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czechia
Fakultni nemocnice Motol; Neurologicka klinika, Praha, , Czechia
Groupe Hospitalier Saint André - Hôpital Saint André, Bordeaux, , France
Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory, Boulogne Billancourt, , France
CHU Clermont Ferrand - Hôpital d'Estaing, Clermont Ferrand cedex 1, , France
CHU de Dijon - Hopital le Bocage, Dijon, , France
Centre Hospitalier Universitaire de Grenoble - Albert Michallon, La Tronche, , France
Hopital Claude Huriez - CHU Lille, Lille, , France
Hopital de la Timone, Marseille, , France
Hopital Saint Eloi, Montpellier, , France
CHU NANTES - Hôtel Dieu; Pharmacy, Nantes, , France
CHU Nice - Hopital de l'Archet 2, Nice, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Hopital Robert Debre; DERMATOLOGIE, Reims, , France
Centre Eugene Marquis; Service d'oncologie, Rennes, , France
St. Josef-Hospital; Studienambulanz, Bochum, , Germany
Elbekliniken Buxtehude GmbH, Buxtehude, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie, Gera, , Germany
Universitätsmedizin Göttingen, Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin, Kiel, , Germany
Universitaetsklinikum Koeln; Hematology/Oncology, Koeln, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Klinikum Mannheim GmbH Universitätsklinikum, Mannheim, , Germany
Fachklinik Hornheide, Muenster, , Germany
Klinikum der Ludwigs-Maximilians-Universitaet Muenchen, München, , Germany
Universitaetsklinikum Regensburg, Regensburg, , Germany
Universitätsklinikum Tübingen, Tuebingen, , Germany
Universitätsklinikum Wurzburg, Würzburg, , Germany
Orszagos Onkologiai Intezet, Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Pecs, , Hungary
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp., Szeged, , Hungary
Soroka Medical Center; Oncology Dept, Beer Sheva, , Israel
Rambam Health Care Campus, Haifa, , Israel
HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus;Hematology-Oncology, Petach Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division, Tel Aviv, , Israel
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Emilia-Romagna, Italy
A.O.U. Policlinico di Modena, Modena, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena IRCCS, Roma, Lazio, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova, Genova, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo, Lombardia, Italy
Asst Degli Spedali Civili Di Brescia, Brescia, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari, Bari, Puglia, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte, Siena, Toscana, Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, Veneto, Italy
Amsterdam UMC Location VUMC, Amsterdam, , Netherlands
Leids Universitair Medisch Centrum; Cardiology, Leiden, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Auckland City Hospital, Auckland, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Radiumhospitalet, Oslo, , Norway
TSBHI Altai Territorial oncological dispensary, Barnaul, , Russian Federation
FSBSI "N. N. Blokhin Russian Cancer Research Center", Moscow, , Russian Federation
Moscow city oncology hospital #62 of Moscow Healthcare Department, Moscow, , Russian Federation
BHI of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
Pyatigorsky Oncologic Dispensary, Pyatigorsk, , Russian Federation
Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, LA Coruña, Spain
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Virgen Macarena, Seville, Sevilla, Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Länssjukhuset Ryhov, Jönköping, , Sweden
Skånes Universitetssjukhus, Lund, , Sweden
Sahlgrenska Sjukhuset, Mölnlycke, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Inselspital-Universitaetsspital Bern, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Barts and the London NHS Trust., London, , United Kingdom
St George's Hospital; Courtyard Clinic, London, , United Kingdom
Royal Marsden Hospital - Fulham, London, , United Kingdom
Royal Marsden Hospital - London, London, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals; QMC Campus, Nottingham, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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