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Profile Name | BRAF act mut |
Gene Variant Detail | |
Relevant Treatment Approaches | MEK inhibitor (Pan) MEK1 Inhibitor MEK2 Inhibitor LY3009120 |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
BRAF act mut | melanoma | no benefit | Sorafenib | Phase II | Actionable | In a Phase II study, Nexavar (sorafenib) displayed negligible efficacy in melanoma patients with BRAF mutations (PMID: 16880785, PMID: 22394203). | 22394203 16880785 | |
BRAF act mut | colorectal cancer | no benefit | Venetoclax + VX-11e | Preclinical - Cell culture | Actionable | In a preclinical study, inhibition of Erk signaling by VX-11e did not sensitize colorectal cancer cell lines harboring KRAS or BRAF activating mutations to Venclexta (venetoclax) in culture (PMID: 27974663). | 27974663 | |
BRAF act mut | thyroid gland cancer | sensitive | Dabrafenib | Guideline | Actionable | Tafinlar (dabrafenib) therapy is included in guidelines for differentiated thyroid carcinoma patients with recurrent, advanced, or metastatic disease harboring BRAF activating mutations, in cases that are not surgically resectable or amenable to radioactive iodine (NCCN.org). | detail... | |
BRAF act mut | melanoma | sensitive | MEK inhibitor (Pan) MEK1 Inhibitor MEK2 Inhibitor | Cobimetinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Cobimetinib (GDC-0973) induced cell death in human melanoma cell lines harboring BRAF activating mutations in culture and inhibited tumor growth in xenograft models (PMID: 22084396). | 22084396 |
BRAF act mut | Advanced Solid Tumor | sensitive | MEK inhibitor (Pan) MEK1 Inhibitor MEK2 Inhibitor | Binimetinib + Encorafenib | Phase Ib/II | Actionable | In a Phase Ib/II trial, Binimetinib (MEK162), in combination with Encorafenib (LGX818), demonstrated safety and efficacy in patients with BRAF mutant advanced solid tumors (J Clin Oncol 31, 2013 (suppl; abstr 9029)). | detail... |
BRAF act mut | thyroid gland papillary carcinoma | sensitive | Vemurafenib | Phase I | Actionable | In a Phase I trial, Zelboraf (vemurafenib) demonstrated safety and efficacy in metastatic papillary thyroid cancer patients carrying BRAF activating mutations (PMID: 23489023). | 23489023 | |
BRAF act mut | lung non-small cell carcinoma | predicted - resistant | Osimertinib | Case Reports/Case Series | Actionable | In a retrospective analysis, activating BRAF mutations were identified in 4 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). | 31839416 | |
BRAF act mut | lung non-small cell carcinoma | sensitive | RAF709 | Preclinical - Pdx | Actionable | In a preclinical study, RAF709 inhibited tumor growth in patient-derived xenograft (PDX) models of non-small cell lung cancer harboring BRAF activating mutations (PMID: 29343524). | 29343524 | |
BRAF act mut | thyroid gland cancer | sensitive | Vemurafenib | Guideline | Actionable | Zelboraf (vemurafenib) therapy is included in guidelines for differentiated thyroid carcinoma patients with recurrent, advanced, or metastatic disease harboring BRAF activating mutations, in cases that are not surgically resectable or amenable to radioactive iodine (NCCN.org). | detail... | |
BRAF act mut | thyroid gland cancer | sensitive | Vemurafenib | Phase I | Actionable | In a Phase I trial, Zelboraf (vemurafenib) demonstrated safety and efficacy in metastatic papillary thyroid cancer patients carrying BRAF activating mutations (PMID: 23489023). | 23489023 | |
BRAF act mut | Advanced Solid Tumor | sensitive | PLX8394 | Preclinical | Actionable | In a preclinical study, PLX8394 had been shown to block survival and growth of vemurafenib/PLX4720-resistant cells harboring distinct BRAF activating mutations (PMID: 24422853). | 24422853 | |
BRAF act mut | colorectal cancer | predicted - sensitive | VX-11e + WEHI-539 | Preclinical - Cell culture | Actionable | In a preclinical study, inhibition of Erk signaling by VX-11e sensitized colorectal cancer cell lines harboring KRAS or BRAF activating mutations to WEHI-539 in culture (PMID: 27974663). | 27974663 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04467801 | Phase II | Ipatasertib Docetaxel + Ipatasertib | Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy | Active, not recruiting | USA | 0 |
NCT01765543 | Phase I | Rifampin + Vemurafenib | A Pharmacokinetics Study to Investigate the Effect of Rifampin on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy | Completed | USA | 4 |
NCT01713972 | Phase I | Dabrafenib + Pazopanib | Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors | Completed | USA | 0 |
NCT04487106 | Phase II | Azacitidine + Trametinib + Venetoclax | Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
NCT02587650 | Phase II | Ceritinib Capmatinib Regorafenib Entrectinib | Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma | Terminated | USA | 0 |
NCT02367859 | Phase II | Dabrafenib + Trametinib | Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma | Completed | USA | 0 |
NCT01636622 | Phase I | Carboplatin + Paclitaxel + Vemurafenib | Study of Vemurafenib, Carboplatin, and Paclitaxel | Completed | USA | 0 |
NCT04534283 | Phase II | Abemaciclib + LY3214996 | A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib. | Recruiting | USA | 0 |
NCT04166487 | Phase II | Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab + Pemetrexed Disodium | Plasma-Adapted First-Line Pembro In NSCLC | Recruiting | USA | 0 |
NCT04222972 | Phase III | Carboplatin + Pembrolizumab + Pemetrexed Disodium Pralsetinib Cisplatin + Gemcitabine Carboplatin + Gemcitabine Cisplatin + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium | AcceleRET Lung Study of Pralsetinib for 1L RET Fusion-positive, Metastatic NSCLC | Recruiting | USA | 13 |
NCT01586195 | Phase II | Vemurafenib | Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E | Terminated | USA | 0 |
NCT03114319 | Phase I | TNO155 | Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors | Recruiting | USA | CAN | 5 |
NCT01596140 | Phase I | Temsirolimus + Vemurafenib Everolimus + Vemurafenib | Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer | Completed | USA | 0 |
NCT03843775 | Phase Ib/II | Binimetinib + Encorafenib | A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers | Recruiting | USA | 0 |
NCT03310541 | Phase I | Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant | AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations | Active, not recruiting | USA | 0 |
NCT02140840 | Phase II | Trametinib | A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib | Withdrawn | USA | 0 |
NCT02012231 | Phase Ib/II | PLX8394 | Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers. | Terminated | USA | 0 |
NCT03088176 | Phase I | Dabrafenib + Talimogene laherparepvec + Trametinib | Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma | Active, not recruiting | USA | 0 |
NCT04612751 | Phase I | DS-1062a + Durvalumab | DS-1062a in Combination With Durvalumab in Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung04) | Recruiting | USA | 1 |
NCT03665129 | Phase I | Durvalumab + IPH5401 | IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors (STELLAR-001) | Active, not recruiting | USA | 1 |
NCT03516981 | Phase II | MK-1308 + Pembrolizumab MK-4280 + Pembrolizumab Lenvatinib + Pembrolizumab | A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) | Recruiting | USA | CAN | 14 |
NCT04249843 | Phase I | BGB3245 | Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors | Recruiting | USA | 1 |
NCT04526509 | Phase I | Cyclophosphamide + Fludarabine GSK3901961 GSK3845097 | Investigation of Autologous Enhanced T Cells in Advanced Tumors | Recruiting | USA | CAN | 0 |
NCT04484142 | Phase II | DS-1062a | Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) | Recruiting | USA | 9 |
NCT02949843 | Phase II | Nivolumab + Pembrolizumab | Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations | Terminated | USA | 0 |
NCT02285439 | Phase Ib/II | Binimetinib | Phase I/II Study of MEK162 for Children With Ras/Raf Pathway Activated Tumors | Active, not recruiting | USA | 0 |
NCT04265534 | Phase II | Carboplatin + Dexamethasone + Pembrolizumab + Pemetrexed Disodium + Telaglenastat Carboplatin + Dexamethasone + Pembrolizumab + Pemetrexed Disodium | KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC (KEAPSAKE) | Recruiting | USA | 0 |
NCT04526691 | Phase I | DS-1062a + Pembrolizumab | DS-1062a in Combination With Pembrolizumab in Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung02) | Recruiting | USA | 1 |
NCT03429803 | Phase Ib/II | MLN2480 | TAK-580 In Gliomas and Other Tumors | Recruiting | USA | 0 |
NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | 1 |