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) 26 MEK1 Inhibitor 26 MEK2 Inhibitor 24 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT02257424 | Phase Ib/II | Dabrafenib + Hydroxychloroquine + Trametinib | Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma (BAMM) | Completed | 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 | Terminated | USA | 0 |
| NCT03754179 | Phase Ib/II | Dabrafenib + Hydroxychloroquine + Trametinib | Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma (COMBI-R2) | Unknown status | BEL | 0 |
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