This is a two-arm, open-label, randomised, Phase III study comparing dabrafenib (GSK2118436)
and trametinib (GSK1120212) combination therapy to vemurafenib. Subjects with
histologically confirmed cutaneous melanoma that is either stage IIIc (unresectable) or
stage IV, and BRAF V600E/K mutation positive will be screened for eligibility. Subjects who
have had prior systemic anti-cancer treatment in the advanced or metastatic setting will not
be eligible although prior systemic treatment in the adjuvant setting will be allowed.
Approximately 694 subjects will be randomised 1: 1 (combination therapy: vemurafenib). The
primary endpoint is overall survival (OS) for subjects receiving the combination therapy
compared with those receiving vemurafenib.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
GSK Investigational Site, Ciudad Autónoma de Buenos Aires C1121ABE, Argentina
GSK Investigational Site, San Miguel de Tucumán T4000IAK, Argentina
GSK Investigational Site, Santa Fe 3000, Argentina
GSK Investigational Site, Graz A-8036, Austria
GSK Investigational Site, Innsbruck 6020, Austria
GSK Investigational Site, Salzburg A-5020, Austria
GSK Investigational Site, Wien 1090, Austria
GSK Investigational Site, Wien A-1030, Austria
GSK Investigational Site, Brasschaat 2930, Belgium
GSK Investigational Site, Brussels 1200, Belgium
GSK Investigational Site, Gent 9000, Belgium
GSK Investigational Site, Jette 1090, Belgium
GSK Investigational Site, Kortrijk 8500, Belgium
GSK Investigational Site, Leuven 3000, Belgium
GSK Investigational Site, Namur 5000, Belgium
GSK Investigational Site, Wilrijk 2610, Belgium
GSK Investigational Site, São Paulo - SP 01323-900, Brazil
GSK Investigational Site, Quebec G1R 2J6, Canada
GSK Investigational Site, Olomouc 775 20, Czech Republic
GSK Investigational Site, Ostrava 708 52, Czech Republic
GSK Investigational Site, Praha 10 100 34, Czech Republic
GSK Investigational Site, Praha 2 128 08, Czech Republic
GSK Investigational Site, Zlin 76275, Czech Republic
GSK Investigational Site, Herlev 2730, Denmark
GSK Investigational Site, Odense 5000 C, Denmark
GSK Investigational Site, Århus C 8000, Denmark
GSK Investigational Site, Helsinki 00029, Finland
GSK Investigational Site, Jyvaskyla 40620, Finland
GSK Investigational Site, Tampere 33520, Finland
GSK Investigational Site, Turku 20520, Finland
GSK Investigational Site, Bordeaux 33075, France
GSK Investigational Site, Grenoble 38043, France
GSK Investigational Site, Lille 59037, France
GSK Investigational Site, Marseille cedex 5 13385, France
GSK Investigational Site, Montpellier cedex 5 34295, France
GSK Investigational Site, Nantes 44093, France
GSK Investigational Site, Nice 06202, France
GSK Investigational Site, Paris Cedex 10 75475, France
GSK Investigational Site, Reims Cedex 51092, France
GSK Investigational Site, Rennes Cedex 35042, France
GSK Investigational Site, Villejuif cedex 94805, France
GSK Investigational Site, Budapest 1062, Hungary
GSK Investigational Site, Budapest H-1122, Hungary
GSK Investigational Site, Debrecen 4032, Hungary
GSK Investigational Site, Győr H-9024, Hungary
GSK Investigational Site, Kaposvár 7400, Hungary
GSK Investigational Site, Miskolc 3526, Hungary
GSK Investigational Site, Szeged 6720, Hungary
GSK Investigational Site, Co.Cork, Ireland
GSK Investigational Site, Dublin 4, Ireland
GSK Investigational Site, Dublin 7, Ireland
GSK Investigational Site, Dublin 9, Ireland
GSK Investigational Site, Galway, Ireland
GSK Investigational Site, Jerusalem, Israel
GSK Investigational Site, Ramat Gan 52621, Israel
GSK Investigational Site, Goyang-si, Gyeonggi-Do 410-769, Korea, Republic of
GSK Investigational Site, Seoul 110-744, Korea, Republic of
GSK Investigational Site, Seoul 135-710, Korea, Republic of
GSK Investigational Site, Amsterdam 1066 CX, Netherlands
GSK Investigational Site, Amsterdam 1081 HV, Netherlands
GSK Investigational Site, Groningen 9713 GZ, Netherlands
GSK Investigational Site, Leeuwarden 8934 AD, Netherlands
GSK Investigational Site, Leiden 2333 ZA, Netherlands
GSK Investigational Site, Rotterdam 3075 EA, Netherlands
GSK Investigational Site, Christchurch 8011, New Zealand
GSK Investigational Site, Newtown, Wellington 6002, New Zealand
GSK Investigational Site, Kristiansand 4604, Norway
GSK Investigational Site, Lørenskog 1478, Norway
GSK Investigational Site, Oslo 0310, Norway
GSK Investigational Site, Gdansk 80-215, Poland
GSK Investigational Site, Konin 62-500, Poland
GSK Investigational Site, Poznan 60-693, Poland
GSK Investigational Site, Warszawa 02-781, Poland
GSK Investigational Site, Chelyabinsk 454087, Russian Federation
GSK Investigational Site, Magnitogorsk 455001, Russian Federation
GSK Investigational Site, Moscow 115478, Russian Federation
GSK Investigational Site, Moscow 143423, Russian Federation
GSK Investigational Site, Nizhniy Novgorod 603081, Russian Federation
GSK Investigational Site, Ryazan 390011, Russian Federation
GSK Investigational Site, St. Petersburg 197758, Russian Federation
GSK Investigational Site, Barcelona 08036, Spain
GSK Investigational Site, Hospitalet de Llobregat, Barcelona 08907, Spain
GSK Investigational Site, Las Palmas De Gran Canaria 35016, Spain
GSK Investigational Site, Madrid 28007, Spain
GSK Investigational Site, Madrid 28050, Spain
GSK Investigational Site, Palma de Mallorca 07010, Spain
GSK Investigational Site, Pamplona 31008, Spain
GSK Investigational Site, Valencia 46009, Spain
GSK Investigational Site, Valencia 46014, Spain
GSK Investigational Site, Linköping SE-581 85, Sweden
GSK Investigational Site, Umeå SE-901 85, Sweden
GSK Investigational Site, Basel 4031, Switzerland
GSK Investigational Site, Lausanne 1011, Switzerland
GSK Investigational Site, Zürich 8091, Switzerland
GSK Investigational Site, Tainan 704, Taiwan
GSK Investigational Site, Taipei 100, Taiwan
GSK Investigational Site, Taoyuan 333, Taiwan
GSK Investigational Site, Dnipropetrovsk 49102, Ukraine
GSK Investigational Site, Donetsk 83092, Ukraine
GSK Investigational Site, Kharkiv 61070, Ukraine
GSK Investigational Site, Kyiv 03022, Ukraine
GSK Investigational Site, Lviv 79031, Ukraine
GSK Investigational Site, Sumy 40005, Ukraine
GSK Investigational Site, Uzhgorod 88017, Ukraine
GSK Investigational Site, Cambridge CB2 0QQ, United Kingdom
GSK Investigational Site, Glasgow G12 0YN, United Kingdom
GSK Investigational Site, London NW3 2QG, United Kingdom
GSK Investigational Site, London SE1 7EH, United Kingdom
GSK Investigational Site, Manchester M20 4BX, United Kingdom
GSK Investigational Site, Southampton SO16 6YD, United Kingdom
GSK Investigational Site, Swansea SA2 8QA, United Kingdom
GSK Investigational Site, Birmingham, Alabama 35243, United States
GSK Investigational Site, Calgary, Alberta T2N 4N2, Canada
GSK Investigational Site, Gilbert, Arizona 85234, United States
GSK Investigational Site, Heidelberg, Baden-Wuerttemberg 69120, Germany
GSK Investigational Site, Heilbronn, Baden-Wuerttemberg 74078, Germany
GSK Investigational Site, Mannheim, Baden-Wuerttemberg 68167, Germany
GSK Investigational Site, Tuebingen, Baden-Wuerttemberg 72076, Germany
GSK Investigational Site, Erlangen, Bayern 91054, Germany
GSK Investigational Site, Muenchen, Bayern 80337, Germany
GSK Investigational Site, Muenchen, Bayern 80802, Germany
GSK Investigational Site, Muenchen, Bayern 80804, Germany
GSK Investigational Site, Nuernberg, Bayern 90419, Germany
GSK Investigational Site, Regensburg, Bayern 93053, Germany
GSK Investigational Site, Wuerzburg, Bayern 97080, Germany
GSK Investigational Site, Kelowna, British Columbia V1Y 5L3, Canada
GSK Investigational Site, Vancouver, British Columbia V5Z 4E6, Canada
GSK Investigational Site, Capital Federal, Buenos Aires C1426ANZ, Argentina
GSK Investigational Site, Beverly Hills, California 90211, United States
GSK Investigational Site, San Francisco, California 94115, United States
GSK Investigational Site, Vallejo, California 94589, United States
GSK Investigational Site, Napoli, Campania 80131, Italy
GSK Investigational Site, Aurora, Colorado 80045, United States
GSK Investigational Site, Jacksonville, Florida 32204, United States
GSK Investigational Site, Miami Beach, Florida 33140, United States
GSK Investigational Site, Orlando, Florida 32804, United States
GSK Investigational Site, Atlanta, Georgia 30322, United States
GSK Investigational Site, Atlanta, Georgia 30341, United States
GSK Investigational Site, Iowa City, Iowa 52242, United States
GSK Investigational Site, Roma, Lazio 00167, Italy
GSK Investigational Site, Genova, Liguria 16132, Italy
GSK Investigational Site, Bergamo, Lombardia 24128, Italy
GSK Investigational Site, Milano, Lombardia 20133, Italy
GSK Investigational Site, Milano, Lombardia 20141, Italy
GSK Investigational Site, Winnipeg, Manitoba R3E 0V9, Canada
GSK Investigational Site, Ann Arbor, Michigan 48109, United States
GSK Investigational Site, Fridley, Minnesota 55432, United States
GSK Investigational Site, St. Louis, Missouri 63110, United States
GSK Investigational Site, Las Vegas, Nevada 89148, United States
GSK Investigational Site, Hackensack, New Jersey 07601, United States
GSK Investigational Site, New Brunswick, New Jersey 08901, United States
GSK Investigational Site, North Sydney, New South Wales 2060, Australia
GSK Investigational Site, Westmead, New South Wales 2145, Australia
GSK Investigational Site, New York, New York 10029, United States
GSK Investigational Site, Buxtehude, Niedersachsen 21614, Germany
GSK Investigational Site, Hannover, Niedersachsen 30625, Germany
GSK Investigational Site, Bonn, Nordrhein-Westfalen 53127, Germany
GSK Investigational Site, Essen, Nordrhein-Westfalen 45122, Germany
GSK Investigational Site, Koeln, Nordrhein-Westfalen 50937, Germany
GSK Investigational Site, Chapel Hill, North Carolina 27599-7600, United States
GSK Investigational Site, Charlotte, North Carolina 28204, United States
GSK Investigational Site, Durham, North Carolina 27710, United States
GSK Investigational Site, Halifax, Nova Scotia B3H 2Y9, Canada
GSK Investigational Site, Cincinnati, Ohio 45219, United States
GSK Investigational Site, Columbus, Ohio 43210, United States
GSK Investigational Site, Kingston, Ontario K7L 5P9, Canada
GSK Investigational Site, Oshawa, Ontario L1G 2B9, Canada
GSK Investigational Site, Ottawa, Ontario K1H 8L6, Canada
GSK Investigational Site, Toronto, Ontario M4N 3M5, Canada
GSK Investigational Site, Toronto, Ontario M5G 2M9, Canada
GSK Investigational Site, Bend, Oregon 97701, United States
GSK Investigational Site, Portland, Oregon 97213, United States
GSK Investigational Site, Portland, Oregon 97239, United States
GSK Investigational Site, Montreal, Quebec H2L 4M1, Canada
GSK Investigational Site, Greenslopes, Queensland 4120, Australia
GSK Investigational Site, Herston, Queensland 4029, Australia
GSK Investigational Site, South Brisbane, Queensland 4101, Australia
GSK Investigational Site, Ludwigshafen, Rheinland-Pfalz 67063, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz 55131, Germany
GSK Investigational Site, Ijui, Rio Grande Do Sul 98700-000, Brazil
GSK Investigational Site, Viedma, Río Negro R8500ACE, Argentina
GSK Investigational Site, Dresden, Sachsen 01307, Germany
GSK Investigational Site, Leipzig, Sachsen 04103, Germany
GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39120, Germany
GSK Investigational Site, Itajaí, Santa Catarina 88301-215, Brazil
GSK Investigational Site, Rosario, Santa Fe S2000KZE, Argentina
GSK Investigational Site, Kiel, Schleswig-Holstein 24105, Germany
GSK Investigational Site, Luebeck, Schleswig-Holstein 23538, Germany
GSK Investigational Site, Woodville, South Australia 5011, Australia
GSK Investigational Site, Charleston, South Carolina 29425, United States
GSK Investigational Site, Greenville, South Carolina 29605, United States
GSK Investigational Site, Nashville, Tennessee 37232-5536, United States
GSK Investigational Site, Dallas, Texas 75246, United States
GSK Investigational Site, Erfurt, Thueringen 99089, Germany
GSK Investigational Site, Gera, Thueringen 07548, Germany
GSK Investigational Site, Pisa, Toscana 56126, Italy
GSK Investigational Site, Salt Lake City, Utah 84106, United States
GSK Investigational Site, Salt Lake City, Utah 84112-5550, United States
GSK Investigational Site, Padova, Veneto 35128, Italy
GSK Investigational Site, Burlington, Vermont 05403, United States
GSK Investigational Site, Box Hill, Victoria 3128, Australia
GSK Investigational Site, Melbourne, Victoria 3004, Australia
GSK Investigational Site, Charlottesville, Virginia 22903, United States
GSK Investigational Site, Nedlands, Western Australia 6009, Australia
GSK Investigational Site, Milwaukee, Wisconsin 53226, United States