A Study of Vemurafenib in Participants With Metastatic Melanoma

An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

Study Overview

• Status: Completed
• Conditions: Malignant Melanoma
• Intervention / Treatment: Drug: Vemurafenib

• Study Type: Interventional
• Enrollment (Actual): 3219
• Phase: Phase 3

Contacts and Locations

Study Locations

• Albania
  • Tirana, Albania, 1000
    • University "Mother Theresa" Hospital Center; Oncology Department
• Argentina
  • Buenos Aires, Argentina, C1426ANZ
    • Inst. Alexander Fleming; Oncologia
  • Buenos Aires, Argentina, C1425DTG
    • Fundacion CIDEA
  • Buenos Aires, Argentina, C1280AEB
    • Hospital Britanico; Oncologia
• Australia
  • New South Wales
    • North Sydney, New South Wales, Australia, 2060
      • Melanoma Institute Australia
    • Waratah, New South Wales, Australia, 2298
      • Newcastle Mater Misericordiae Hospital; Oncology
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
    • Wodonga, New South Wales, Australia, 3690
      • Border Medical Oncology
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Greenslopes Private Hospital; Gallipoli Research Centre
    • Townsville, Queensland, Australia, 4812
      • The Townsville Hospital; Townsville Cancer Centre
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital; Oncology
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Geelong Hospital; Geelong Cardiology Practice
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre; Medical Oncology
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Austria
  • Feldkirch, Austria, 6807
    • Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin
  • Graz, Austria, 8036
    • LKH Graz; Abteilung für allgemeine Dermatologie
  • Innsbruck, Austria, 6020
    • LKH Innsbruck; Universitätsklinik für Dermatologie
  • Linz, Austria, 4020
    • Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie
  • Salzburg, Austria, 5020
    • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Salzburg, Austria, 5020
    • LKH Salzburg; Universitätsklinik für Dermatologie
  • St. Pölten, Austria, 3100
    • Landesklinikum St. Pölten
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Univ.Klinik für Dermatologie
• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Wilrijk, Belgium, 2610
    • Sint Augustinus Wilrijk
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Center of the Republic of Srpska
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinic of Oncology, University Clinical Center Sarajevo
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20230-130
      • Instituto Nacional de Cancer - INCa; Pesquisa Clinica
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Hospital das Clinicas - UFRGS
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo, SP, Brazil, 01509-010
      • Hospital A. C. Camargo; Oncologia
    • São Paulo, SP, Brazil, CEP 01321-001
      • Hospital São José
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • District Oncology Dispensary; Department for Oncology and Dermatology
  • Sofia, Bulgaria, 1756
    • National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute ; Dept of Medical Oncology
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7L 2L7
      • Lion's Gate Hospital
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital; Medicine
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII HSC; Oncology
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Hamilton Health Sciences - Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital; Division of Infectious Diseases
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
    • Quebec City, Quebec, Canada, G1R 2J6
      • Chuq - Hopital Hotel Dieu de Quebec; Oncology
• Colombia
  • Bogota, Colombia
    • Centro Javeriano de Oncología
  • Bogota, Colombia
    • Fundacion Santa Fe de Bogota
  • Cali, Colombia
    • Clínica Imbanaco; Oncology
  • Medellin-Antioquia, Colombia
    • Hospital Pablo Tobón Uribe
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sisters of Mercy
• Czechia
  • Brno, Czechia, 656 53
    • Masarykův onkologický ústav; Klinika komplexní onkologické péče
  • Hradec Kralove, Czechia, 500 05
    • University Hospital; Oncology and Radiotherapy
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Ostrava, Czechia, 708 52
    • Faculty Hospital; Dialysis Unit
  • Praha, Czechia, 128 00
    • 1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus
  • Praha, Czechia
    • Faculty Hospital Kralovske Vinohrady; Oncology
• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus Universitetshospital; Kræftafdelingen
  • Herlev, Denmark, 2730
    • Herlev Hospital; Onkologisk afdeling
  • Odense, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
• Ecuador
  • Cuenca, Ecuador
    • Hospital Regional Vicente Corral Moscoso, Servicio de Oncología
  • Guayaquil, Ecuador, EC090104
    • Hospital Abel Gilbert Ponton; Oncology
  • Portoviejo, Ecuador, EC130104
    • Hospital Solca Portoviejo; Oncologia
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation; Oncology Center
  • Tallinn, Estonia, 11312
    • East Tallinn Central Hospital; Clinic of Internal Medicine
  • Tartu, Estonia, 50406
    • Tartu University Hospital; Clinic of Hematology and Oncology
• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital; Dept of Oncology
  • Tampere, Finland, 33520
    • Tampere University Hospital; Dept of Oncology
  • Turku, Finland, 20520
    • Turku Uni Central Hospital; Oncology Clinics
• Germany
  • Aachen, Germany, 52074
    • Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik
  • Augsburg, Germany, 86179
    • Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie
  • Berlin, Germany, 12200
    • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
  • Bochum, Germany, 44791
    • St. Josef-Hospital Klinik f. Dermatologie u. Allergologie
  • Buxtehude, Germany, 21614
    • Elbekliniken Buxtehude; Klinik für Dermatologie
  • Chemnitz, Germany, 09117
    • DRK-Krankenhaus; Hautklinik
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf; Hautklinik
  • Erfurt, Germany, 99089
    • HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Hautklinik
  • Essen, Germany, 45122
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60596
    • Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie
  • Freiburg, Germany, 79104
    • Uniklinikum Freiburg Dermatol
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
  • Hannover, Germany, 30449
    • Medizinische Hochschule; Hautklinik Linden
  • Heidelberg, Germany, 69115
    • Uni-Hautklinik
  • Heilbronn, Germany, 74078
    • Klinikum am Gesundbrunnen; Tumorzentrum
  • Jena, Germany, 07743
    • Universitätsklinikum Jena; Klinik für Hautkrankheiten
  • Kassel, Germany, 34125
    • Klinikum Kassel; Hautklinik
  • Kiel, Germany, 24105
    • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
  • Köln, Germany, 50937
    • Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie
  • Ludwigshafen, Germany, 67063
    • Klinikum d.Stadt Ludwigshafen Hautklinik
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein; Campus Lübeck
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
  • Mainz, Germany, 55131
    • Johannes Gutenberg Unis-Klinik; Dept For Dermatology
  • Mannheim, Germany, 68167
    • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
  • Marburg, Germany, 35043
    • Universitätsklinikum Marburg Klinik f. Dermatologie
  • Minden, Germany, 32429
    • Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik
  • München, Germany, 80337
    • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
  • München, Germany, 80804
    • Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Münster, Germany, 48157
    • Fachklinik Hornheide; Internistische Onkologie
  • Nürnberg, Germany, 90419
    • Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
  • Quedlinburg, Germany, 06484
    • Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie
  • Recklinghausen, Germany, 45657
    • KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
  • Tübingen, Germany, 72076
    • Universitaets-Hautklinik Tuebingen
  • Wiesbaden, Germany, 65191
    • Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie
  • Wuppertal, Germany, 42283
    • HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
• Greece
  • Athens, Greece, 115 27
    • Laiko General Hospital; 1St Pathological Clinic
  • Athens, Greece, 15123
    • Hospital Hygeia; 1St Oncology Dept.
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Piraeus, Greece, 185 47
    • Metropolitan Hospital; Dept. of Oncology
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
  • Debrecen, Hungary, 4012
    • Debreceni Egyetem OEC; Borgyogyaszati Klinika
  • Pecs, Hungary, 7632
    • Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika
  • Szeged, Hungary, 6720
    • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
• India
  • Hyderabad, India, 500034
    • Basavatarakam Indo-American Cancer Hospital & Research Institute
  • Lucknow, India, 226003
    • Chhatrapati Shahuji Maharaj Medical University; Department of Oncology
  • Trivandrum, India, 695 011
    • Regional Cancer Centre; Dept of Oncology
  • Vellore, India, 632004
    • Christian Med Clg & Hspt
  • Delhi
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial Hospital; Dept of Medical Oncology
    • Nashik, Maharashtra, India, 422004
      • Curie Manavata Cancer Centre
• Ireland
  • Cork, Ireland
    • Cork Uni Hospital; Oncology Dept
  • Dublin, Ireland, 4
    • St Vincent'S Uni Hospital; Medical Oncology
  • Dublin, Ireland, 7
    • Mater Misericordiae Uni Hospital; Oncology
  • Dublin, Ireland, 7
    • Mater Private Hospital
  • Dublin, Ireland
    • St James' Hospital; Cancer Clinical Trials Office
  • Galway, Ireland
    • Galway Uni Hospital; Oncology Dept
  • Limerick, Ireland
    • University Hospital Limerick - Oncology
  • Waterford, Ireland
    • Waterford Regional Hospital; Department Of Medical Oncology
• Israel
  • Beer Sheva, Israel, 8410101
    • Soroka Medical Center; Oncology Dept
  • Hafia, Israel, 3109601
    • Ranbam Health Care Campus; Oncology - Hafia
  • Jerusalem, Israel, 91120-01
    • Hadassah Ein Karem Hospital; Oncology Dept
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center; Oncology Dept
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Modena, Emilia-Romagna, Italy, 41100
      • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • Lazio
    • Roma, Lazio, Italy, 00168
      • IFO - Istituto Regina Elena; Oncologia Medica
    • Roma, Lazio, Italy, 00167
      • Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Lombardia
    • Bergamo, Lombardia, Italy, 24128
      • Asst Papa Giovanni XXIII; Oncologia Medica
    • Brescia, Lombardia, Italy, 25123
      • Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
    • Milano, Lombardia, Italy, 20141
      • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
    • Milano, Lombardia, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
    • Milano, Lombardia, Italy, 20132
      • Irccs Ospedale San Raffaele;Oncologia Medica
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • Policlinico Le Molinette; Clinica Dermatologica
  • Puglia
    • Bari, Puglia, Italy, 70126
      • Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
  • Toscana
    • Firenze, Toscana, Italy, 50139
      • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
    • Pisa, Toscana, Italy, 50126
      • Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina
    • Siena, Toscana, Italy, 53100
      • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Umbria
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera S. Maria - Terni; Oncologia
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University Severance Hospital; Medical Oncology
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Seoul St Mary's Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hosp; Dept Internal Med Hem Onc
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center.
• Latvia
  • Daugavpils, Latvia, 5417
    • Daugavpils Regional Hospital
  • Riga, Latvia, LV 1079
    • Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs
• Lithuania
  • Klaipeda, Lithuania, 92288
    • Klaipeda university hospital
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies
• Mexico
  • Leon, Mexico, 37000
    • Fundación Rodolfo Padilla Padilla, A.C.; Oncology
  • Mexico City, Mexico, 14000
    • Inst. Nacional de Cancerologia; Investigacion Clinica
  • Mexico DF, Mexico, 06726
    • Hospital General de México; Unidad de Oncologia
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
  • Amsterdam, Netherlands, 1081 HV
    • VU MEDISCH CENTRUM; Dept. of Medical Oncology
  • Blaricum, Netherlands, 1261 AN
    • Tergooiziekenhuizen
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • Academ Ziekenhuis Groningen; Medical Oncology
  • Leiden, Netherlands, 2333 ZA
    • Academisch Ziekenhuis Leiden; Clinical Oncology
  • Maastricht, Netherlands, 6229 HX
    • Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
  • Nijmegen, Netherlands, 6500 HB
    • UMC St Radboud; Interne Oncologie; Medical Oncology Department
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
• Norway
  • Bergen, Norway, 5021
    • Haukeland Universitetshospital; Onkologisk Avd.
  • Oslo, Norway, 0379
    • The Norvegian Radium Hospital Montebello; Dept of Oncology
• Peru
  • Arequipa, Peru, 04001
    • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
  • Lima, Peru, 34
    • Instituto Nacional de Enfermedades Neoplasicas
• Poland
  • Krakow, Poland, 31-531
    • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • Olsztyn, Poland, 10-228
    • ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37
  • Poznań, Poland, 60-693
    • NZOZ Med.-Polonia sp. z o.o.
  • Warszawa, Poland, 02-781
    • Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
• Portugal
  • Lisboa, Portugal, 1099-023
    • IPO de Lisboa; Servico de Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Romania
  • Bucuresti, Romania, 022328
    • Institut of Oncology Al. Trestioreanu Bucharest; Oncology
  • Cluj-Napoca, Romania, 400058
    • Medisprof SRL
  • Timisoara, Romania, 300167
    • S.C. Life Search S.R.L; Medical Oncology Clinic
• Russian Federation
  • Krasnodar, Russian Federation, 350040
    • Regional Clinical Oncology Dispensary
  • Moscow, Russian Federation, 143423
    • Moscow city oncology hospital #62 of Moscow Healthcare Department
  • Moscow, Russian Federation, 115478
    • Russian Cancer Research Center
  • Saint-Petersburg, Russian Federation, 197022
    • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
  • Stavropol, Russian Federation, ND
    • Stavropol Clinical Oncology Dispansary
  • UFA, Russian Federation, 450054
    • Bashkirian Republican Clinical Oncology Dispensary
  • Leningrad
    • St Petersburg, Leningrad, Russian Federation, 197758
      • FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia; Medical Oncology
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska Kosa; Oncology
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E
  • Bratislava, Slovakia, 812 50
    • Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie
  • Poprad, Slovakia, 058 01
    • POKO Poprad; Department of Oncology
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
• South Africa
  • Bloemfontein, South Africa, 9300
    • Universitas Annex, University of the Free State; Clinical Oncology
  • Cape Town, South Africa, 7570
    • Cape Town Oncology Trials
  • Cape Town, South Africa, 7700
    • Cancercare
  • Johannesburg, South Africa, 2196
    • Medical Oncology Centre of Rosebank; Oncology
  • Pretoria, South Africa, 0002
    • Steve Biko Academic Hospital; Oncology
  • Sandton, South Africa, 2196
    • Sandton Oncology Centre
• Spain
  • Barcelona, Spain, 08035
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Cordoba, Spain, 14004
    • Hospital Reina Sofia
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  • La Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
  • Leon, Spain, 24071
    • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 41014
    • Hospital General Universitario de Valencia; Servicio de oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
      • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
  • Murcia
    • Cartagena (Murcia), Murcia, Spain, 30202
      • Hospital Universitario de Santa Lucía; Servicio de Oncología Médica
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Hospital Xeral Cíes; Servicio de Oncologia
  • Tenerife
    • La Laguna (Tenerife), Tenerife, Spain, 38320
      • Hospital Universitario de Canarias (HUC)
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Oncologia
• Sweden
  • Gothenburg, Sweden, SE-41 343
    • Sahlgrenska Universitetssjukhuset; Onkology
  • Lund, Sweden, 22185
    • Skånes Onkologiska Klinik, Universitetssjukhuset
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Solna
  • Umeå, Sweden
    • Norrlands universitetssjukhus; Onkologkliniken
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset, Onkologkliniken
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel; Onkologie
  • Bern, Switzerland, 3010
    • Inselspital Bern; Medizinische Onkologie
  • Chur, Switzerland, 7000
    • Kantonsspital Graubünden;Onkologie und Hämatologie
  • Lausanne, Switzerland, 1011
    • CHUV; Departement d'Oncologie
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen; Onkologie/Hämatologie
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich; Dermatologische Klinik
• Turkey
  • Adana, Turkey, 01330
    • Cukurova Uni Faculty of Medicine; Medical Oncology
  • Adana, Turkey, 01120
    • Adana Baskent University Hospital; Medical Oncology
  • Ankara, Turkey, 06500
    • Gazi Uni Medical Faculty Hospital; Oncology Dept
  • Ankara, Turkey, 06230
    • Ankara Uni , Ibn-I Sina Hospital; Oncology Dept
  • Antalya, Turkey, 07000
    • Akdeniz University School of Medicine; General Surgery
  • Bornova, İZMİR, Turkey, 35100
    • Ege University Medical Faculty; Medical Oncology Department
  • Gaziantep, Turkey, 27310
    • Gaziantep University Medical Faculty, Medical Oncology Department
  • Istanbul, Turkey, 34300
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Istanbul, Turkey, 34000
    • Kartal Training and Research Hospital;Medical Oncology Department
  • Istanbul, Turkey, 34365
    • American Hospital, Medical Oncology Department
  • Izmir, Turkey, 35340
    • Dokuz Eylul Uni ; Medical Oncology
  • Sıhhiye, ANKARA, Turkey, 06100
    • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey County Hospital; St. Lukes Cancer Centre
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • Manchester, United Kingdom, M20 4QL
    • Christie Hospital; Breast Cancer Research Office
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Hospital; Centre For Cancer Treatment
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals City Campus
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital; Oxford Cancer and Haematology Centre
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital; Medical Oncology
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital; Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
• Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
• Participants may or may not have received prior systemic therapy for metastatic melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
• Adequate hematologic, renal and liver function

Exclusion Criteria:

• Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
• Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
• Concurrent administration of any anti-cancer therapies other than those administered in the study
• Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
• Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vemurafenib; Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.	Drug: Vemurafenib; Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.; Other Names: RO5185426, Zelboraf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0	The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: Grade 3 means "Severe"; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means "Life-threatening, Disabling"; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable.	Baseline up to 28 days post end of treatment (maximum up to 46 months)
Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation	An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.	Baseline up to 28 days post end of treatment (maximum up to 46 months)
Percentage of Participants With AEs of Special Interest	AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).	Baseline up to 28 days post end of treatment (maximum up to 46 months)
Mean Cumulative Dose of Vemurafenib		Baseline up to end of treatment or death (maximum up to 46 months)
Duration of Vemurafenib Treatment	Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted. Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation.	Baseline up to end of treatment or death (maximum upto 46 months)
Mean Total Vemurafenib Dose Per Day	Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted. Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment.	Baseline up to end of treatment or death (maximum up to 46 months)
Dose Intensity of Vemurafenib	Dose intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.	Baseline up to end of treatment or death (maximum upto 46 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status	ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.	Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)
Percentage of Participants Who Received Any Concomitant Medications	Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.	Baseline up to 46 months
Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response.	Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Duration of Response	The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.	From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months])
Time to Response	Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response.	Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Percentage of Participants With PD Assessed According to RECIST v1.1 or Death	PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.	Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Progression Free Survival (PFS)	PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.	Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])
Percentage of Participants Who Died		Baseline until death (maximum up to 46 months)
Overall Survival (OS)	Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.	Baseline until death (maximum up to 46 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Larkin J, Brown MP, Arance AM, Hauschild A, Queirolo P, Vecchio MD, Ascierto PA, Krajsova I, Schachter J, Neyns B, Garbe C, Sileni VC, Mandala M, Gogas H, Espinosa E, Hospers G, Lorigan P, Nyakas M, Guminski A, Liszkay G, Rutkowski P, Miller W Jr, Donica M, Makrutzki M, Blank C. An open-label, multicentre safety study of vemurafenib in patients with BRAFV600-mutant metastatic melanoma: final analysis and a validated prognostic scoring system. Eur J Cancer. 2019 Jan;107:175-185. doi: 10.1016/j.ejca.2018.11.018. Epub 2018 Dec 20.
• Larkin J, Del Vecchio M, Ascierto PA, Krajsova I, Schachter J, Neyns B, Espinosa E, Garbe C, Sileni VC, Gogas H, Miller WH Jr, Mandala M, Hospers GA, Arance A, Queirolo P, Hauschild A, Brown MP, Mitchell L, Veronese L, Blank CU. Vemurafenib in patients with BRAF(V600) mutated metastatic melanoma: an open-label, multicentre, safety study. Lancet Oncol. 2014 Apr;15(4):436-44. doi: 10.1016/S1470-2045(14)70051-8. Epub 2014 Feb 27.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): February 24, 2016
• Study Completion (Actual): February 24, 2016

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Vemurafenib
• Other Study ID Numbers: MO25515; 2010-023526-21 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No