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Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: Dabrafenib (Drug); Vemurafenib (Drug); Trametinib (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival

Secondary outcome:

Progression-free Survival, as Assessed by the Investigator

Overall Response, as Assessed by the Investigator

Duration of Response, as Assessed by the Investigator

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- >= 18 years of age

- Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma

- Measurable disease according to RECIST 1. 1

- Women of childbearing potential with negative serum pregnancy test prior to

randomisation

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate baseline organ function

Exclusion Criteria:

- Any prior use of a BRAF or MEK inhibitor

- Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior

systemic treatment in the adjuvant setting is allowed

- History of another malignancy (except subjects who have been disease free for 3 years

or with a history of completely resected non-melanoma skin cancer)

- Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which

will be allowed)

- Brain metastases (except if all known lesions were previously treated with surgery or

stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation

- History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood

pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy)

- History or current evidence/risk of retinal vein occlusion (RVO) or central serous

retinopathy (CSR)

Locations and Contacts

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

Additional Information

Starting date: June 2012
Last updated: December 4, 2014

Page last updated: August 23, 2015

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