Therapy Detail
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| Therapy Name | Dabrafenib + Pembrolizumab + 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). |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov). |
| 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 V600K | skin melanoma | sensitive | Dabrafenib + Pembrolizumab + Trametinib | Guideline | Actionable | Tafinlar (dabrafenib) plus Mekinist (trametinib) in combination with an immune checkpoint inhibitor, such as Keytruda (pembrolizumab), is included in guidelines as second-line or subsequent therapy (category 2A) for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 mutation, such as BRAF V600K (NCCN.org). | detail... |
| BRAF V600X | skin melanoma | sensitive | Dabrafenib + Pembrolizumab + Trametinib | Guideline | Actionable | Tafinlar (dabrafenib) plus Mekinist (trametinib) in combination with an immune checkpoint inhibitor, such as Keytruda (pembrolizumab), is included in guidelines as second-line or subsequent therapy (category 2A) for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 mutation (NCCN.org). | detail... |
| BRAF V600E | melanoma | predicted - sensitive | Dabrafenib + Pembrolizumab + Trametinib | Phase II | Actionable | In a Phase II trial (IMPemBra), Keytruda (pembrolizumab) in combination with short-term or intermittent Tafinlar (dabrafenib) plus Mekinist (trametinib) resulted in improved median progression-free survival compared to Keytruda (pembrolizumab) monotherapy (27.0 vs 10.6 mo, p=0.13) in patients with treatment-naive advanced melanoma harboring BRAF V600E (n=26) or V600K (n=6) mutations (J Clin Oncol 38: 2020 (suppl; abstr 10021); NCT02625337). | detail... |
| BRAF V600K | melanoma | predicted - sensitive | Dabrafenib + Pembrolizumab + Trametinib | Phase II | Actionable | In a Phase II trial (IMPemBra), Keytruda (pembrolizumab) in combination with short-term or intermittent Tafinlar (dabrafenib) plus Mekinist (trametinib) resulted in improved median progression-free survival compared to Keytruda (pembrolizumab) monotherapy (27.0 vs 10.6 mo, p=0.13) in patients with treatment-naive advanced melanoma harboring BRAF V600E (n=26) or V600K (n=6) mutations (J Clin Oncol 38: 2020 (suppl; abstr 10021); NCT02625337). | detail... |
| BRAF V600E | skin melanoma | sensitive | Dabrafenib + Pembrolizumab + Trametinib | Guideline | Actionable | Tafinlar (dabrafenib) plus Mekinist (trametinib) in combination with an immune checkpoint inhibitor, such as Keytruda (pembrolizumab), is included in guidelines as second-line or subsequent therapy (category 2A) for patients with metastatic or unresectable cutaneous melanoma harboring a BRAF V600 mutation, such as BRAF V600E (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03149029 | Phase II | Dabrafenib + Pembrolizumab + Trametinib Pembrolizumab + Trametinib | Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma | Active, not recruiting | USA | 0 |
| NCT02130466 | Phase Ib/II | Dabrafenib + Trametinib Pembrolizumab + Trametinib Dabrafenib + Pembrolizumab Dabrafenib + Pembrolizumab + Trametinib | A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022) | Completed | 0 | |
| NCT04675710 | Phase II | Dabrafenib + Pembrolizumab + Trametinib | Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer | Recruiting | USA | 0 |
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