Therapy Detail

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Therapy Name Dabrafenib + Hydroxychloroquine + Trametinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Dabrafenib Tafinlar GSK2118436 BRAF Inhibitor 25 Tafinlar (dabrafenib) inhibits the activity of BRAF, including V600E, which results in the inhibition of tumor cell proliferation (PMID: 22735384). Tafinlar (dabrafenib) is FDA approved for BRAF V600E/K- positive unresectable or metastatic melanoma, and in combination with Mekinist (trametinib) for BRAF V600E/K-mutant melanoma, BRAF V600E-mutant non-small cell lung cancer, BRAF V600E-mutant anaplastic thyroid cancer, for adult and pediatric patients of 6 years or older with unresectable or metastatic solid tumors harboring BRAF V600E, and for pediatric patients of 1 year or older with low-grade glioma harboring BRAF V600E (FDA.gov).
Hydroxychloroquine Plaquenil HCQ Plaquenil (hydroxychloroquine sulfate) increases intralysosomal pH, resulting in inhibition of autophagic protein degradation and accumulation of autophagosomes, which potentially leads to cell death in autophagy-dependent tumor cells (NCI Drug Dictionary).
Trametinib Mekinist GSK1120212 MEK inhibitor (Pan) 23 MEK1 Inhibitor 25 MEK2 Inhibitor 23 Mekinist (trametinib) inhibits MEK 1 and 2, which potentially leads to reduced tumor cell proliferation (PMID: 27956260). Mekinist (trametinib) is FDA approved for melanoma patients harboring BRAF V600E or BRAF V600K mutations, and in combination with Tafinlar (dabrafenib) for BRAF V600E/K-mutant melanoma, BRAF V600E- mutant non-small cell lung cancer, BRAF V600E-mutant anaplastic thyroid cancer, for adult and pediatric patients of 6 years or older with unresectable or metastatic solid tumors harboring BRAF V600E, and for pediatric patients of 1 year or older with low-grade glioma harboring BRAF V600E (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600X melanoma predicted - sensitive Dabrafenib + Hydroxychloroquine + Trametinib Phase Ib/II Actionable In a Phase I/II trial (BAMM), the combination of Tafinlar (dabrafenib), Mekinist (trametinib), and Plaquenil (hydroxychloroquine sulfate) resulted in a 1-year progression-free survival (PFS) rate of 48.2%, a median PFS of 11.2 mo, a response rate (RR) of 85% (29/34, 14 complete, 15 partial responses), and median overall survival (OS) of 26.5 mo in patients with advanced BRAF V600-mutant melanoma, RR, mPFS, and OS were 88%, 7.3, and 22 mo in patients with elevated LDH (n=16) (PMID: 35022320; NCT02257424). 35022320

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03754179 Phase Ib/II Dabrafenib + Hydroxychloroquine + Trametinib Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma (COMBI-R2) Unknown status BEL 0
NCT04201457 Phase Ib/II Hydroxychloroquine + Trametinib Dabrafenib + Hydroxychloroquine + Trametinib A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration Recruiting USA 0
NCT04527549 Phase II Dabrafenib + Trametinib Dabrafenib + Hydroxychloroquine + Trametinib Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma Active, not recruiting USA 0
NCT02257424 Phase Ib/II Dabrafenib + Hydroxychloroquine + Trametinib Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma (BAMM) Completed USA 0


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