Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
NCT ID: NCT02039947
Last Updated: 2019-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2014-02-21
2018-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Cohort A
Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.
Dabrafenib
Dabrafenib will be provided as 50 mg and 75 mg capsules
Trametinib
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Cohort B
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Dabrafenib
Dabrafenib will be provided as 50 mg and 75 mg capsules
Trametinib
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Cohort C
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Dabrafenib
Dabrafenib will be provided as 50 mg and 75 mg capsules
Trametinib
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Cohort D
Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity
Dabrafenib
Dabrafenib will be provided as 50 mg and 75 mg capsules
Trametinib
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Interventions
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Dabrafenib
Dabrafenib will be provided as 50 mg and 75 mg capsules
Trametinib
Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.
* May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma.
* Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.
Exclusion Criteria
* Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
* Treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe.
* Any presence of leptomeningeal disease or any parenchymal brain metastasis
* History of another malignancy, some exceptions may apply.
* A history or evidence of cardiovascular risk- specific criteria have to be met
* A history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment - specific criteria have to be met.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Chapel Hill, North Carolina, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
North Sydney, New South Wales, Australia
Novartis Investigative Site
Greenslopes, Queensland, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Boulogne-Billancourt, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pierre-Bénite, , France
Novartis Investigative Site
Poitiers, , France
Novartis Investigative Site
Rennes, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, Germany
Novartis Investigative Site
Tübingen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Hanover, Lower Saxony, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Kiel, Schleswig-Holstein, Germany
Novartis Investigative Site
Gera, Thuringia, Germany
Novartis Investigative Site
Milan, Lombardy, Italy
Novartis Investigative Site
Milan, Lombardy, Italy
Novartis Investigative Site
Padua, Veneto, Italy
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Las Palmas de Gran Canaria, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Málaga, , Spain
Novartis Investigative Site
Palma de Mallorca, , Spain
Novartis Investigative Site
Pamplona, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Zaragoza, , Spain
Countries
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References
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Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.
Davies MA, Saiag P, Robert C, Grob JJ, Flaherty KT, Arance A, Chiarion-Sileni V, Thomas L, Lesimple T, Mortier L, Moschos SJ, Hogg D, Marquez-Rodas I, Del Vecchio M, Lebbe C, Meyer N, Zhang Y, Huang Y, Mookerjee B, Long GV. Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):863-873. doi: 10.1016/S1470-2045(17)30429-1. Epub 2017 Jun 4.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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117277
Identifier Type: -
Identifier Source: org_study_id
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