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Dabrafenib in Combination With Trametinib
Source: Agnostic Cancer Therapies (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 12, 2025 · Captured 2026-09-09.
Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary. Independent clinical review is pending.
Context: BRAF V600E Variant–Positive Solid Tumors
Indication. The combination of dabrafenib and trametinib is indicated for adult and pediatric patients aged 6 years or older with unresectable or metastatic solid tumors and a BRAF V600E variant. Patients must have progressive disease after prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
Evidence. The U.S. Food and Drug Administration approval was based on data from the following populations:[1-5][Level of evidence C3]
Source links and citations
Two open-label multiple cohort trials included 131 adult patients: BRF117019 (NCT02034110) (median follow-up, 47 weeks), and NCI-MATCH (NCT02465060) protocol H (median follow-up, 23.0 months).[1-3]
One trial included 36 pediatric patients: CTMT212X2101 (NCT02124772) (median follow-up, not defined).[4]
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The approval was also supported by results from COMBI-d (NCT01072175), COMBI-v (NCT01597908), and BRF113928 (NCT01336634).[6]
Efficacy. For the 131 adult patients, the overall response rate was 41% (95% confidence interval [CI], 33%–50%). For the 36 pediatric patients, the overall response rate was 25% (95% CI, 12%–42%).[5]
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Identification of biomarker. Biomarker status was determined at a Clinical Laboratory Improvement Amendments (CLIA) or CLIA-equivalent laboratory.
Studies cited in this source section
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Preserved source evidence · Independent clinical review pending · Not medical advice