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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 | 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 | 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 | 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 | 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 | |
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 | 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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03429803 | Phase I | MLN2480 | DAY101 In Gliomas and Other Tumors | Active, not recruiting | 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 |
NCT04984811 | Phase II | Atezolizumab + NT-I7 | NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC | Recruiting | USA | 0 |
NCT04526691 | Phase I | Cisplatin + Datopotamab Deruxtecan + Pembrolizumab Carboplatin + Datopotamab Deruxtecan + Pembrolizumab Datopotamab Deruxtecan + Pembrolizumab | Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02) | Recruiting | USA | ITA | ESP | 2 |
NCT05006794 | Phase I | GS-9716 + Sacituzumab govitecan-hziy GS-9716 Docetaxel + GS-9716 | Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies | 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) | Terminated | USA | 0 |
NCT04644237 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) | Active, not recruiting | USA | ITA | FRA | ESP | CAN | 5 |
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) | Active, not recruiting | USA | ITA | ESP | CAN | 12 |
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 |
NCT03310541 | Phase I | Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant | AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations | Active, not recruiting | USA | 0 |
NCT01596140 | Phase I | Temsirolimus + Vemurafenib Everolimus + Vemurafenib | Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer | 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 |
NCT04484142 | Phase II | Datopotamab Deruxtecan | Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 5 |
NCT03665129 | Phase I | Durvalumab + IPH5401 | IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors (STELLAR-001) | Terminated | USA | FRA | 0 |
NCT05340621 | Phase Ib/II | Binimetinib + OKI-179 | OKI-179 Plus Binimetinib in Patients With Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2) | Recruiting | USA | 0 |
NCT04108026 | Phase II | Durvalumab | Immunotherapy in Patient With Poor General Condition (SAVIMMUNE) | Recruiting | FRA | 0 |
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 |
NCT03843775 | Phase Ib/II | Binimetinib + Encorafenib | A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers | Recruiting | USA | 0 |
NCT05111561 | Phase I | Binimetinib + ZEN-3694 | Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer | Recruiting | USA | 0 |
NCT05200481 | Phase II | Brigatinib + Carboplatin + Pemetrexed Disodium Brigatinib | Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK) | Active, not recruiting | FRA | 0 |
NCT04534283 | Phase II | Abemaciclib + LY3214996 | A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib. | 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 |
NCT04249843 | Phase I | BGB3245 | Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors | Recruiting | USA | 1 |
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 |
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 |
NCT04612751 | Phase I | Datopotamab Deruxtecan + Durvalumab | Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab With or Without Carboplatin in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04) | Recruiting | USA | FRA | 1 |
NCT05313009 | Phase Ib/II | Sotorasib + TH-4000 | Tarlox and Sotorasib in Patients With KRAS G12C Mutations | Recruiting | USA | 0 |
NCT04166487 | Phase II | Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab + Pemetrexed Disodium | Plasma-Adapted First-Line Pembro In NSCLC | Recruiting | USA | 0 |
NCT04775485 | Phase II | MLN2480 | A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma (FIREFLY-1) | Recruiting | USA | DEU | CAN | 6 |
NCT01713972 | Phase I | Dabrafenib + Pazopanib | Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors | Completed | USA | 0 |
NCT02367859 | Phase II | Dabrafenib + Trametinib | Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma | Completed | 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 |
NCT03827850 | Phase II | Erdafitinib | FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) | Recruiting | DEU | 0 |
NCT04811001 | Phase II | Dacomitinib Osimertinib | Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) | Recruiting | ITA | 0 |
NCT01636622 | Phase I | Carboplatin + Paclitaxel + Vemurafenib | Study of Vemurafenib, Carboplatin, and Paclitaxel | Completed | USA | 0 |
NCT04699188 | Phase Ib/II | JDQ443 JDQ443 + TNO155 JDQ443 + Spartalizumab JDQ443 + Spartalizumab + TNO155 | Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 9 |
NCT04222972 | Phase III | Carboplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Pralsetinib Cisplatin + Gemcitabine Carboplatin + Gemcitabine Cisplatin + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium | A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 17 |
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 |
NCT04169841 | Phase II | Durvalumab + Olaparib + Tremelimumab | Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment (GUIDE2REPAIR) | Recruiting | FRA | 0 |
NCT03114319 | Phase I | TNO155 | Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors | Recruiting | USA | ESP | CAN | 5 |
NCT04467801 | Phase II | Ipatasertib Docetaxel + Ipatasertib | Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy | Recruiting | USA | 0 |