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Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
Sponsor: Novartis Pharmaceuticals
Summary
This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk (Stage IIIa \[lymph node metastasis \>1 mm\], IIIb or IIIc) cutaneous melanoma were screened for eligibility. Approximately 852 patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc). Patients received either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or 2 matching placebos (one each for dabrafenib and trametinib) for 12 months or until disease recurrence, death, unacceptable toxicity, or withdrawal of consent. Patients were followed for disease recurrence and survival during and after the treatment period. The study did not permit crossover. Doses of study treatment could be modified and/or interrupted for management of toxicities associated with study treatment.
Official title: COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
870
Start Date
2013-01-08
Completion Date
2023-07-31
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Dabrafenib
Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)
Trametinib
Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
Placebos
The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment
Locations (168)
Novartis Investigative Site
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Lake Worth, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Lutherville-Timonium, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Capital Federal, Buenos Aires, Argentina
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Buenos Aires, Argentina
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Gateshead, New South Wales, Australia
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North Sydney, New South Wales, Australia
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Tweed Heads, New South Wales, Australia
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Westmead, New South Wales, Australia
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Greenslopes, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Box Hill, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Graz, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Wels, Austria
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Wilrijk, Belgium
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Curitiba, Paraná, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Brno, Czechia
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Prague, Czechia
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Prague, Czechia
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Zlín, Czechia
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Arhus C, Denmark
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Herlev, Denmark
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Odense, Denmark
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Bordeaux, France
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Boulogne-Billancourt, France
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Brest, France
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Dijon, France
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Grenoble, France
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Lille, France
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Marseille, France
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Montpellier, France
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Nice, France
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Paris, France
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Paris, France
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Pierre-Bénite, France
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Reims, France
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Rennes, France
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Toulouse, France
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Tours, France
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Villejuif, France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Heilbronn, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Darmstadt, Hesse, Germany
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Marburg, Hesse, Germany
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Wiesbaden, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Bochum, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Kiel, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Erfurt, Thuringia, Germany
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Gera, Thuringia, Germany
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Berlin, Germany
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Athens, Greece
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Thessaloniki, Greece