AzTrials
AzTrials

Malignant MelanomaPhase 3NCT01307397

A Study of Vemurafenib in Participants With Metastatic Melanoma

A Phase 3 study testing Vemurafenib in people with Malignant Melanoma, run by Hoffmann-La Roche at 280 sites in 44 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Vemurafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,219 participants
Where
280 sitesin 44 countries
Study dates
1 Mar 2011to 24 Feb 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

280 sites in 44 countries.

280 sites in 44 countries

Germany43 sites

  • Uniklinik RWTH Aachen; Klinik für Dermatologie und Allergologie - Hautklinik

    Aachen, 52074

  • Klinikum Augsburg Süd; Klinik für Dermatologie und Allergologie

    Augsburg, 86179

  • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

    Berlin, 12200

  • St. Josef-Hospital Klinik f. Dermatologie u. Allergologie

    Bochum, 44791

  • Elbekliniken Buxtehude; Klinik für Dermatologie

    Buxtehude, 21614

  • DRK-Krankenhaus; Hautklinik

    Chemnitz, 09117

  • Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

    Cologne, 50937

  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

    Dresden, 01307

  • Universitätsklinikum Düsseldorf; Hautklinik

    Düsseldorf, 40225

  • HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie

    Erfurt, 99089

  • Universitätsklinikum Erlangen; Hautklinik

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinik Johann Wolfgang von Goethe Uni; Klinik fuer Allgemein- und Viszeralchirurgie

    Frankfurt, 60596

  • Uniklinikum Freiburg Dermatol

    Freiburg im Breisgau, 79104

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548

  • Universitätsmedizin Göttingen Georg-August-Universität Zentrum Dermatologie

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

    Hamburg, 20246

  • Medizinische Hochschule; Hautklinik Linden

    Hanover, 30449

  • Uni-Hautklinik

    Heidelberg, 69115

  • Klinikum am Gesundbrunnen; Tumorzentrum

    Heilbronn, 74078

  • Universitätsklinikum Jena; Klinik für Hautkrankheiten

    Jena, 07743

  • Klinikum Kassel; Hautklinik

    Kassel, 34125

  • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

    Kiel, 24105

  • Universitätsklinikum Leipzig Klinik f.Dermatologie Venerologie u.Allergologie

    Leipzig, 04103

  • Universitätsklinikum Schleswig-Holstein; Campus Lübeck

    Lübeck, 23538

  • Klinikum d.Stadt Ludwigshafen Hautklinik

    Ludwigshafen, 67063

  • Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

    Magdeburg, 39120

  • Johannes Gutenberg Unis-Klinik; Dept For Dermatology

    Mainz, 55131

  • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

    Mannheim, 68167

  • Universitätsklinikum Marburg Klinik f. Dermatologie

    Marburg, 35043

  • Johannes-Wesling-Klinikum Minden; Onkologische Ambulanz / Tagesklinik

    Minden, 32429

  • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

    München, 80337

  • Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie

    München, 80804

  • Universitätsklinikum Münster

    Münster, 48149

  • Fachklinik Hornheide; Internistische Onkologie

    Münster, 48157

  • Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

    Nuremberg, 90419

  • Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie

    Quedlinburg, 06484

  • KLINIKUM VEST GmbH Knappschaftskrankenhaus Abt.Haut- Allergie- Venen- und Umwelterkrankungen

    Recklinghausen, 45657

  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

    Regensburg, 93053

  • Universitaets-Hautklinik Tuebingen

    Tübingen, 72076

  • Wilhelm Fresenius Klinik; Klinik f. Dermatologie u. Allergologie

    Wiesbaden, 65191

  • HELIOS Klinikum Barmen Zentrum Dermatologie Allergologie und Umweltmedizin

    Wuppertal, 42283

  • Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

    Würzburg, 97080

Other trials in Germany

Spain27 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

    A Coruña, La Coruña, 15006

  • Hospital de Cruces; Servicio de Oncologia

    Barakaldo, Vizcaya, 48903

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Barcelona, 08916

  • Hospital Universitario de Santa Lucía; Servicio de Oncología Médica

    Cartagena (Murcia), Murcia, 30202

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

    Granada, 18014

  • Hospital Universitario de Canarias (HUC)

    La Laguna (Tenerife), Tenerife, 38320

  • Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia

    León, 24071

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

    Málaga, 29010

  • Hospital Univ. Central de Asturias; Servicio de Oncologia

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    Seville, 41009

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 41014

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Xeral Cíes; Servicio de Oncologia

    Vigo, Pontevedra, 36312

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Italy21 sites

  • Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

    Bari, Apulia, 70126

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24128

  • Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

    Brescia, Lombardy, 25123

  • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

    Florence, Tuscany, 50139

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Irccs Ospedale San Raffaele;Oncologia Medica

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milan, Lombardy, 20141

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41100

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

    Padova, Veneto, 35128

  • Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1

    Palermo, Sicily, 90127

  • Azienda Ospedaliera S. Chiara; Dip di Onc,Trapianti e delle Nuove Tecnologie in Medicina

    Pisa, Tuscany, 50126

  • AO Santa Maria Nuova; U.O. Day Hospital di Oncologi

    Reggio Emilia, Emilia-Romagna, 42100

  • Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

    Rome, Lazio, 00167

  • IFO - Istituto Regina Elena; Oncologia Medica

    Rome, Lazio, 00168

  • A.O.U. Senese Policlinico Santa Maria Alle Scotte

    Siena, Tuscany, 53100

  • Azienda Ospedaliera S. Maria - Terni; Oncologia

    Terni, Umbria, 05100

  • Policlinico Le Molinette; Clinica Dermatologica

    Turin, Piedmont, 10126

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Australia12 sites

  • Royal Adelaide Hospital; Oncology

    Adelaide, South Australia, 5000

  • Geelong Hospital; Geelong Cardiology Practice

    Geelong, Victoria, 3220

  • Greenslopes Private Hospital; Gallipoli Research Centre

    Greenslopes, Queensland, 4120

  • Peter MacCallum Cancer Centre; Medical Oncology

    Melbourne, Victoria, 3000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060

  • The Townsville Hospital; Townsville Cancer Centre

    Townsville, Queensland, 4812

  • Newcastle Mater Misericordiae Hospital; Oncology

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Border Medical Oncology

    Wodonga, New South Wales, 3690

  • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada12 sites

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • QEII HSC; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • Lion'S Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • The Ottawa Hospital; Division of Infectious Diseases

    Ottawa, Ontario, K1H 8L6

  • Chuq - Hopital Hotel Dieu de Quebec; Oncology

    Québec, Quebec, G1R 2J6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • St. Boniface General Hospital; Medicine

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Turkey (Türkiye)12 sites

  • Adana Baskent University Hospital; Medical Oncology

    Adana, 01120

  • Cukurova Uni Faculty of Medicine; Medical Oncology

    Adana, 01330

  • Ankara Uni , Ibn-I Sina Hospital; Oncology Dept

    Ankara, 06230

  • Gazi Uni Medical Faculty Hospital; Oncology Dept

    Ankara, 06500

  • Akdeniz University School of Medicine; General Surgery

    Antalya, 07000

  • Ege University Medical Faculty; Medical Oncology Department

    Bornova, İ̇zmi̇r, 35100

  • Gaziantep University Medical Faculty, Medical Oncology Department

    Gaziantep, 27310

  • Kartal Training and Research Hospital;Medical Oncology Department

    Istanbul, 34000

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • American Hospital, Medical Oncology Department

    Istanbul, 34365

  • Dokuz Eylul Uni ; Medical Oncology

    Izmir, 35340

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

United Kingdom12 sites

  • Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

    Cambridge, CB2 0QQ

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Royal Surrey County Hospital; St. Lukes Cancer Centre

    Guildford, GU2 7XX

  • St James University Hospital

    Leeds, LS9 7TF

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Christie Hospital; Breast Cancer Research Office

    Manchester, M20 4QL

  • Northern Centre for Cancer Care Freeman Hospital; Sir Bobby Robson Cancer Trials Research Centre

    Newcastle upon Tyne, NE7 7DN

  • Mount Vernon Hospital; Centre For Cancer Treatment

    Northwood, HA6 2RN

  • Nottingham University Hospitals City Campus

    Nottingham, NG5 1PB

  • Churchill Hospital; Oxford Cancer and Haematology Centre

    Oxford, OX3 7LJ

  • Southampton General Hospital; Medical Oncology

    Southampton, SO16 6YD

  • Singleton Hospital; Oncology

    Swansea, SA2 8QA

Other trials in United Kingdom

Netherlands10 sites

  • Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

    Amsterdam, 1066 CX

  • VU MEDISCH CENTRUM; Dept. of Medical Oncology

    Amsterdam, 1081 HV

  • Tergooiziekenhuizen

    Blaricum, 1261 AN

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Academ Ziekenhuis Groningen; Medical Oncology

    Groningen, 9713 GZ

  • Academisch Ziekenhuis Leiden; Clinical Oncology

    Leiden, 2333 ZA

  • Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

    Maastricht, 6229 HX

  • UMC St Radboud; Interne Oncologie; Medical Oncology Department

    Nijmegen, 6500 HB

  • Erasmus MC

    Rotterdam, 3000 CA

  • Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.

    Utrecht, 3584 CX

Other trials in Netherlands

Austria8 sites

  • Landeskrankenhaus Feldkirch; Abteilung für Innere Medizin

    Feldkirch, 6807

  • LKH Graz; Abteilung für allgemeine Dermatologie

    Graz, 8036

  • LKH Innsbruck; Universitätsklinik für Dermatologie

    Innsbruck, 6020

  • Krankenhaus der Elisabethinen Linz; Abteilung für Dermatologie

    Linz, 4020

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • LKH Salzburg; Universitätsklinik für Dermatologie

    Salzburg, 5020

  • Landesklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien; Univ.Klinik für Dermatologie

    Vienna, 1090

Other trials in Austria

Ireland8 sites

  • Cork Uni Hospital; Oncology Dept

    Cork

  • St Vincent'S Uni Hospital; Medical Oncology

    Dublin, 4

  • Mater Misericordiae Uni Hospital; Oncology

    Dublin, 7

  • Mater Private Hospital

    Dublin, 7

  • St James' Hospital; Cancer Clinical Trials Office

    Dublin

  • Galway Uni Hospital; Oncology Dept

    Galway

  • University Hospital Limerick - Oncology

    Limerick

  • Waterford Regional Hospital; Department Of Medical Oncology

    Waterford

Other trials in Ireland

India7 sites

  • Basavatarakam Indo-American Cancer Hospital & Research Institute

    Hyderabad, 500034

  • Chhatrapati Shahuji Maharaj Medical University; Department of Oncology

    Lucknow, 226003

  • Tata Memorial Hospital; Dept of Medical Oncology

    Mumbai, Maharashtra, 400012

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra, 422004

  • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

    New Delhi, National Capital Territory of Delhi, 110085

  • Regional Cancer Centre; Dept of Oncology

    Trivandrum, 695 011

  • Christian Med Clg & Hspt

    Vellore, 632004

Other trials in India

Russia7 sites

  • Regional Clinical Oncology Dispensary

    Krasnodar, 350040

  • Russian Cancer Research Center

    Moscow, 115478

  • Moscow city oncology hospital #62 of Moscow Healthcare Department

    Moscow, 143423

  • FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF

    Saint Petersburg, Sankt-Peterburg, 197758

  • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • Stavropol Clinical Oncology Dispansary

    Stavropol, ND

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, 450054

Other trials in Russia

Czechia6 sites

  • Masarykův onkologický ústav; Klinika komplexní onkologické péče

    Brno, 656 53

  • University Hospital; Oncology and Radiotherapy

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • Faculty Hospital; Dialysis Unit

    Ostrava, 708 52

  • 1 Lekarska Fakulta Uni Karlovy; 3 Interni Klinika, Labor. Pro Endokrinologii A Metabolismus

    Prague, 128 00

  • Faculty Hospital Kralovske Vinohrady; Oncology

    Prague

Other trials in Czechia

South Africa6 sites

  • Universitas Annex, University of the Free State; Clinical Oncology

    Bloemfontein, 9300

  • Cape Town Oncology Trials

    Cape Town, 7570

  • Cancercare

    Cape Town, 7700

  • Medical Oncology Centre of Rosebank; Oncology

    Johannesburg, 2196

  • Steve Biko Academic Hospital; Oncology

    Pretoria, 0002

  • Sandton Oncology Centre

    Sandton, 2196

Other trials in South Africa

Switzerland6 sites

  • Universitaetsspital Basel; Onkologie

    Basel, 4031

  • Inselspital Bern; Medizinische Onkologie

    Bern, 3010

  • Kantonsspital Graubünden;Onkologie und Hämatologie

    Chur, 7000

  • CHUV; Departement d'Oncologie

    Lausanne, 1011

  • Kantonsspital St. Gallen; Onkologie/Hämatologie

    Sankt Gallen, 9007

  • Universitätsspital Zürich; Dermatologische Klinik

    Zurich, 8091

Other trials in Switzerland

Brazil5 sites

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Instituto Nacional de Cancer - INCa; Pesquisa Clinica

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital A. C. Camargo; Oncologia

    São Paulo, São Paulo, 01509-010

  • Hospital Sao Jose

    São Paulo, São Paulo, CEP 01321-001

Other trials in Brazil

Hungary5 sites

  • Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

    Budapest, 1085

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Debreceni Egyetem OEC; Borgyogyaszati Klinika

    Debrecen, 4012

  • Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

    Pécs, 7632

  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

    Szeged, 6720

Other trials in Hungary

South Korea5 sites

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Seoul National University Hosp; Dept Internal Med Hem Onc

    Seoul, 110-744

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

  • Asan Medical Center.

    Seoul, 138-736

Other trials in South Korea

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset; Onkology

    Gothenburg, SE-41 343

  • Skånes Onkologiska Klinik, Universitetssjukhuset

    Lund, 22185

  • Karolinska Universitetssjukhuset, Solna

    Stockholm, 171 76

  • Norrlands universitetssjukhus; Onkologkliniken

    Umeå

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

Colombia4 sites

  • Centro Javeriano de Oncología

    Bogotá

  • Fundacion Santa Fe de Bogotá

    Bogotá

  • Clínica Imbanaco; Oncology

    Cali

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

Other trials in Colombia

Greece4 sites

  • Laiko General Hospital; 1St Pathological Clinic

    Athens, 115 27

  • Hospital Hygeia; 1St Oncology Dept.

    Athens, 15123

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • Metropolitan Hospital; Dept. of Oncology

    Piraeus, 185 47

Other trials in Greece

Israel4 sites

  • Soroka Medical Center; Oncology Dept

    Beersheba, 8410101

  • Ranbam Health Care Campus; Oncology - Hafia

    Hafia, 3109601

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 91120-01

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

Other trials in Israel

Poland4 sites

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 31-531

  • ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37

    Olsztyn, 10-228

  • NZOZ Med.-Polonia sp. z o.o.

    Poznan, 60-693

  • Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Argentina3 sites

  • Hospital Britanico; Oncologia

    Buenos Aires, C1280AEB

  • Fundación CIDEA

    Buenos Aires, C1425DTG

  • Inst. Alexander Fleming; Oncologia

    Buenos Aires, C1426ANZ

Other trials in Argentina

Belgium3 sites

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Denmark3 sites

  • Aarhus Universitetshospital; Kræftafdelingen

    Aarhus C, 8000

  • Herlev Hospital; Onkologisk afdeling

    Herlev, 2730

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense, 5000

Other trials in Denmark

Ecuador3 sites

  • Hospital Regional Vicente Corral Moscoso, Servicio de Oncología

    Cuenca

  • Hospital Abel Gilbert Ponton; Oncology

    Guayaquil, EC090104

  • Hospital Solca Portoviejo; Oncologia

    Portoviejo, EC130104

Other trials in Ecuador

Estonia3 sites

  • East Tallinn Central Hospital; Clinic of Internal Medicine

    Tallinn, 11312

  • North Estonia Medical Centre Foundation; Oncology Center

    Tallinn, 13419

  • Tartu University Hospital; Clinic of Hematology and Oncology

    Tartu, 50406

Other trials in Estonia

Finland3 sites

  • Helsinki University Central Hospital; Dept of Oncology

    Helsinki, 00029

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520

  • Turku Uni Central Hospital; Oncology Clinics

    Turku, 20520

Other trials in Finland

Mexico3 sites

  • Fundación Rodolfo Padilla Padilla, A.C.; Oncology

    León, 37000

  • Hospital General de México; Unidad de Oncologia

    Mexico City, 06726

  • Inst. Nacional de Cancerologia; Investigacion Clinica

    Mexico City, 14000

Other trials in Mexico

Romania3 sites

  • Institut of Oncology Al. Trestioreanu Bucharest; Oncology

    Bucharest, 022328

  • Medisprof SRL

    Cluj-Napoca, 400058

  • S.C. Life Search S.R.L; Medical Oncology Clinic

    Timișoara, 300167

Other trials in Romania

Slovakia3 sites

  • Onkologicky ustav sv. Alzbety; Oddelenie ambulantnej chemoterapie

    Bratislava, 812 50

  • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

    Bratislava, 833 10

  • POKO Poprad; Department of Oncology

    Poprad, 058 01

Other trials in Slovakia

Bosnia and Herzegovina2 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Bulgaria2 sites

  • District Oncology Dispensary; Department for Oncology and Dermatology

    Plovdiv, 4000

  • National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

    Sofia, 1756

Other trials in Bulgaria

Latvia2 sites

  • Daugavpils Regional Hospital

    Daugavpils, 5417

  • Rigas Austrumu Kliniska Universitates slimnica, Latvijas Onkologijas centrs

    Riga, LV 1079

Other trials in Latvia

Lithuania2 sites

  • Klaipeda University Hospital

    Klaipėda, 92288

  • Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

    Vilnius, 08661

Other trials in Lithuania

Norway2 sites

  • Haukeland Universitetshospital; Onkologisk Avd.

    Bergen, 5021

  • The Norvegian Radium Hospital Montebello; Dept of Oncology

    Oslo, 0379

Other trials in Norway

Peru2 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

    Arequipa, 04001

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 34

Other trials in Peru

Portugal2 sites

  • IPO de Lisboa; Servico de Oncologia Medica

    Lisbon, 1099-023

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Serbia2 sites

  • Institute for Oncology and Radiology of Serbia; Medical Oncology

    Belgrade, 11000

  • Clinical Center Bezanijska Kosa; Oncology

    Belgrade, 11080

Other trials in Serbia

Albania1 site

  • University "Mother Theresa" Hospital Center; Oncology Department

    Tirana, 1000

Other trials in Albania

Croatia1 site

  • Clinical Hospital Sisters of Mercy

    Zagreb, 10000

Other trials in Croatia

North Macedonia1 site

  • University Clinic for Radiotherapy and Oncology Skopje; Department of skin malignancies

    Skopje, 1000

Other trials in North Macedonia

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: 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.

Being tested
Vemurafenib
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VemurafenibDrug

    Also called RO5185426, Zelboraf

    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.

Study groups in NCT01307397
Study groupRoleWhat they receive
VemurafenibExperimentalParticipants 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.
Receives: Drug: Vemurafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 28 days post end of treatment (maximum up to 46 months)

  2. 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.

    Measured: Baseline up to 28 days post end of treatment (maximum up to 46 months)

  3. 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).

    Measured: Baseline up to 28 days post end of treatment (maximum up to 46 months)

  4. Mean Cumulative Dose of Vemurafenib

    Measured: Baseline up to end of treatment or death (maximum up to 46 months)

  5. 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.

    Measured: Baseline up to end of treatment or death (maximum upto 46 months)

  6. 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.

    Measured: Baseline up to end of treatment or death (maximum up to 46 months)

  7. 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.

    Measured: Baseline up to end of treatment or death (maximum upto 46 months)

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)

  2. 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.

    Measured: Baseline up to 46 months

  3. 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.

    Measured: 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])

  4. 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.

    Measured: 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])

  5. 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.

    Measured: 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])

  6. 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.

    Measured: 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])

  7. 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.

    Measured: 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])

  8. Percentage of Participants Who Died

    Measured: Baseline until death (maximum up to 46 months)

  9. 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.

    Measured: Baseline until death (maximum up to 46 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2011 (estimated)
  2. Study start1 Mar 2011
  3. Primary completion24 Feb 2016
  4. Study completion24 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307397
Sponsor's protocol ID
MO25515
Other IDs
2010-023526-21
Status last verified
Jul 2017
First submitted
17 Feb 2011
Last updated
18 Dec 2017
FDA-regulated device
No

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.

    PubMed 30580112

  • 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.

    PubMed 24582505

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vemurafenib in people with Malignant Melanoma, run by Hoffmann-La Roche at 280 sites in 44 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 280 sites in Germany, Spain, Italy, Australia, Canada and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline up to 28 days post end of treatment (maximum up to 46 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01307397, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.

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