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Spots Global Cancer Trial Database for Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

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Trial Identification

Brief Title: Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

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

Study ID: NCT01682083

Conditions

Melanoma

Study Description

Brief Summary: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two 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. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or two placebos for 12 months.

Detailed Description: This was a two-arm, randomized, double-blind, multi-center, international phase III study of dabrafenib in combination with trametinib versus two matching 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. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]). None of the patients had undergone previous systemic anticancer treatment or radiotherapy for melanoma. All the patients had undergone completion lymphadenectomy with no clinical or radiographic evidence of residual regional node disease within 12 weeks before randomization, had recovered from definitive surgery, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. BRAF V600 mutation status was confirmed in primary-tumor or lymph-node tissue by a central reference laboratory. All the patients provided written informed consent. The primary end point was recurrence-free survival, Overall survival, as the key secondary end point, was to be tested in a hierarchical manner only if the primary end point met the criteria for significance. The overall survival analysis used a preplanned three-look Lan-DeMets group sequential design with an O'Brien-Fleming-type boundary, which was used to determine the significance threshold for the first interim overall survival analysis (two-sided P=0.000019). Disease assessments included clinical examination and imaging by means of computed tomography, magnetic resonance imaging, or both.) Imaging was performed every 3 months during the first 24 months, then every 6 months until disease recurrence or the completion of the trial. Follow-up for survival began after recurrence and continued through the end of the trial. Adverse events and laboratory values were assessed at screening, on the date of randomization, at least once per month through month 12, and at every visit for disease-recurrence assessment after month 12. Adverse events and laboratory values were graded according to the Common Terminology Criteria for Adverse Events, version 4.0.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, Birmingham, Alabama, United States

Novartis Investigative Site, Tucson, Arizona, United States

Novartis Investigative Site, San Francisco, California, United States

Novartis Investigative Site, San Francisco, California, United States

Novartis Investigative Site, Aurora, Colorado, United States

Novartis Investigative Site, Farmington, Connecticut, United States

Novartis Investigative Site, Fort Myers, Florida, United States

Novartis Investigative Site, Lake Worth, Florida, United States

Novartis Investigative Site, Orlando, Florida, United States

Novartis Investigative Site, Saint Petersburg, Florida, United States

Novartis Investigative Site, Stuart, Florida, United States

Novartis Investigative Site, Tampa, Florida, United States

Novartis Investigative Site, Atlanta, Georgia, United States

Novartis Investigative Site, Atlanta, Georgia, United States

Novartis Investigative Site, Indianapolis, Indiana, United States

Novartis Investigative Site, Baltimore, Maryland, United States

Novartis Investigative Site, Lutherville-Timonium, Maryland, United States

Novartis Investigative Site, Boston, Massachusetts, United States

Novartis Investigative Site, Ann Arbor, Michigan, United States

Novartis Investigative Site, Morristown, New Jersey, United States

Novartis Investigative Site, Winston-Salem, North Carolina, United States

Novartis Investigative Site, Cincinnati, Ohio, United States

Novartis Investigative Site, Columbus, Ohio, United States

Novartis Investigative Site, Portland, Oregon, United States

Novartis Investigative Site, Pittsburgh, Pennsylvania, United States

Novartis Investigative Site, Nashville, Tennessee, United States

Novartis Investigative Site, Nashville, Tennessee, United States

Novartis Investigative Site, Dallas, Texas, United States

Novartis Investigative Site, Murray, Utah, United States

Novartis Investigative Site, Seattle, Washington, United States

Novartis Investigative Site, Capital Federal, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Viedma, Río Negro, Argentina

Novartis Investigative Site, Rosario, Santa Fe, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Santa Fe, , Argentina

Novartis Investigative Site, Gateshead, New South Wales, Australia

Novartis Investigative Site, North Sydney, New South Wales, Australia

Novartis Investigative Site, Tweed Heads, New South Wales, Australia

Novartis Investigative Site, Westmead, New South Wales, Australia

Novartis Investigative Site, Greenslopes, Queensland, Australia

Novartis Investigative Site, Milton, Queensland, Australia

Novartis Investigative Site, Woolloongabba, Queensland, Australia

Novartis Investigative Site, Adelaide, South Australia, Australia

Novartis Investigative Site, Box Hill, Victoria, Australia

Novartis Investigative Site, Heidelberg, Victoria, Australia

Novartis Investigative Site, Melbourne, Victoria, Australia

Novartis Investigative Site, Nedlands, Western Australia, Australia

Novartis Investigative Site, Graz, , Austria

Novartis Investigative Site, Innsbruck, , Austria

Novartis Investigative Site, Linz, , Austria

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Wels, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Brussels, , Belgium

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Liege, , Belgium

Novartis Investigative Site, Wilrijk, , Belgium

Novartis Investigative Site, Goiania, Goiás, Brazil

Novartis Investigative Site, Curitiba, Paraná, Brazil

Novartis Investigative Site, Ijui, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Rio De Janeiro, , Brazil

Novartis Investigative Site, São Paulo, , Brazil

Novartis Investigative Site, Edmonton, Alberta, Canada

Novartis Investigative Site, Hamilton, Ontario, Canada

Novartis Investigative Site, Oshawa, Ontario, Canada

Novartis Investigative Site, Ottawa, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Quebec, , Canada

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Hradec Kralove, , Czechia

Novartis Investigative Site, Olomouc, , Czechia

Novartis Investigative Site, Praha 10, , Czechia

Novartis Investigative Site, Praha 2, , Czechia

Novartis Investigative Site, Zlin, , Czechia

Novartis Investigative Site, Arhus C, , Denmark

Novartis Investigative Site, Herlev, , Denmark

Novartis Investigative Site, Odense, , Denmark

Novartis Investigative Site, Bordeaux, , France

Novartis Investigative Site, Boulogne-Billancourt, , France

Novartis Investigative Site, Brest cedex, , France

Novartis Investigative Site, Dijon, , France

Novartis Investigative Site, Grenoble, , France

Novartis Investigative Site, Lille, , France

Novartis Investigative Site, Marseille cedex 5, , France

Novartis Investigative Site, Montpellier cedex 5, , France

Novartis Investigative Site, Nice, , France

Novartis Investigative Site, Paris Cedex 10, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Pierre-Benite cedex, , France

Novartis Investigative Site, Reims Cedex, , France

Novartis Investigative Site, Rennes Cedex, , France

Novartis Investigative Site, Toulouse cedex 9, , France

Novartis Investigative Site, Tours Cedex 9, , France

Novartis Investigative Site, Villejuif cedex, , France

Novartis Investigative Site, Freiburg, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Heidelberg, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Heilbronn, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Mannheim, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Tuebingen, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Ulm, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Nuernberg, Bayern, Germany

Novartis Investigative Site, Regensburg, Bayern, Germany

Novartis Investigative Site, Wuerzburg, Bayern, Germany

Novartis Investigative Site, Darmstadt, Hessen, Germany

Novartis Investigative Site, Kassel, Hessen, Germany

Novartis Investigative Site, Marburg, Hessen, Germany

Novartis Investigative Site, Wiesbaden, Hessen, Germany

Novartis Investigative Site, Schwerin, Mecklenburg-Vorpommern, Germany

Novartis Investigative Site, Buxtehude, Niedersachsen, Germany

Novartis Investigative Site, Hannover, Niedersachsen, Germany

Novartis Investigative Site, Aachen, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Bochum, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Bonn, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Muenster, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Mainz, Rheinland-Pfalz, Germany

Novartis Investigative Site, Homburg, Saarland, Germany

Novartis Investigative Site, Magdeburg, Sachsen-Anhalt, Germany

Novartis Investigative Site, Quedlinburg, Sachsen-Anhalt, Germany

Novartis Investigative Site, Kiel, Schleswig-Holstein, Germany

Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany

Novartis Investigative Site, Erfurt, Thueringen, Germany

Novartis Investigative Site, Gera, Thueringen, Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Athens, , Greece

Novartis Investigative Site, Thessaloniki, , Greece

Novartis Investigative Site, Thessaloniki, , Greece

Novartis Investigative Site, Jerusalem, , Israel

Novartis Investigative Site, Ramat Gan, , Israel

Novartis Investigative Site, Roma, Lazio, Italy

Novartis Investigative Site, Genova, Liguria, Italy

Novartis Investigative Site, Bergamo, Lombardia, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Candiolo, Piemonte, Italy

Novartis Investigative Site, Pisa, Toscana, Italy

Novartis Investigative Site, Padova, Veneto, Italy

Novartis Investigative Site, Shizuoka, , Japan

Novartis Investigative Site, Tokyo, , Japan

Novartis Investigative Site, Amsterdam, , Netherlands

Novartis Investigative Site, Amsterdam, , Netherlands

Novartis Investigative Site, Groningen, , Netherlands

Novartis Investigative Site, Leeuwarden, , Netherlands

Novartis Investigative Site, Maastricht, , Netherlands

Novartis Investigative Site, Nijmegen, , Netherlands

Novartis Investigative Site, Rotterdam, , Netherlands

Novartis Investigative Site, Auckland, , New Zealand

Novartis Investigative Site, Alesund, , Norway

Novartis Investigative Site, Oslo, , Norway

Novartis Investigative Site, Gdansk, , Poland

Novartis Investigative Site, Konin, , Poland

Novartis Investigative Site, Poznan, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Chelyabinsk, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Ryazan, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, Volgograd, , Russian Federation

Novartis Investigative Site, Badalona, , Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Cartagena, , Spain

Novartis Investigative Site, Las Palmas De Gran Canaria, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Malaga, , Spain

Novartis Investigative Site, Palma de Mallorca, , Spain

Novartis Investigative Site, Pamplona, , Spain

Novartis Investigative Site, San Sebastian, , Spain

Novartis Investigative Site, Santander, , Spain

Novartis Investigative Site, Sevilla, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Goteborg, , Sweden

Novartis Investigative Site, Lund, , Sweden

Novartis Investigative Site, Stockholm, , Sweden

Novartis Investigative Site, Uppsala, , Sweden

Novartis Investigative Site, Basel, , Switzerland

Novartis Investigative Site, Chur, , Switzerland

Novartis Investigative Site, Zurich, , Switzerland

Novartis Investigative Site, Taichung, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Taoyuan, , Taiwan

Novartis Investigative Site, Northwood, Middlesex, United Kingdom

Novartis Investigative Site, Exeter, , United Kingdom

Novartis Investigative Site, Glasgow, , United Kingdom

Novartis Investigative Site, Guildford, , United Kingdom

Novartis Investigative Site, Leeds, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Manchester, , United Kingdom

Novartis Investigative Site, Newcastle upon Tyne, , United Kingdom

Novartis Investigative Site, Norwich, , United Kingdom

Novartis Investigative Site, Preston, , United Kingdom

Novartis Investigative Site, Southampton, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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