{"id":"encorafenib-only-treatment","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT05203172","NCT01981187","NCT03915951","NCT04657991","NCT05446142","NCT03864042","NCT02928224","NCT05217446","NCT01719380","NCT03693170","NCT05926960","NCT01909453","NCT04800822","NCT04607421","NCT05097599","NCT03911869","NCT04585815","NCT02109653"],"aliases":[],"patents":[],"pricing":[],"allNames":"encorafenib only treatment","offLabel":[],"timeline":[{"date":"2015","type":"negative","milestone":"Phase 2 Initiated","description":"Phase 2 trial (LGX818 for Patients With BRAFV600 Mutated Tumors) — Solid Tumor. Trial terminated early."},{"date":"2016","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF ) — Melanoma"},{"date":"2022","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient) — Advanced Solid Tumors"},{"date":"2029","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo) — Solid Tumors"}],"aiSummary":"Encorafenib is a BRAF inhibitor that blocks a specific cancer-causing protein mutation found in melanoma and other cancers. It works by targeting cells with the BRAF V600E/K mutation, preventing them from growing and dividing. This targeted approach allows for more precise treatment with potentially fewer side effects compared to traditional chemotherapy.","brandName":"Encorafenib only Treatment","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent","explanation":"Cancer cells sometimes develop a mutation in a gene called BRAF that causes the protein it produces to become permanently stuck in the \"on\" position. This mutated BRAF protein continuously sends growth signals to the cancer cell, telling it to divide and spread without stopping. Encorafenib is designed to fit into and block this mutated BRAF protein, essentially turning off the faulty growth signal that drives the cancer.\n\nBy blocking the mutated BRAF protein, encorafenib prevents cancer cells from receiving the signals they need to survive and multiply. This selective targeting means the drug primarily affects cancer cells that carry this specific mutation while generally sparing normal cells that don't have the problem. The result is that tumors stop growing and often begin to shrink as the cancer cells either die or stop dividing.\n\nThis approach represents a shift toward personalized medicine in cancer treatment—rather than using drugs that poison all rapidly dividing cells indiscriminately, encorafenib targets a specific molecular defect found in certain cancers. This precision typically means patients may experience different side effects than with traditional chemotherapy, and treatment can be more effective for those whose tumors have the BRAF mutation.","oneSentence":"Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"encorafenib-only-treatment","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Solid Tumors","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05203172","phase":"Phase 4","title":"The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo","status":"Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":46,"indication":"Solid Tumors","completionDate":"2029-07","primaryEndpoint":"The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib"},{"nctId":"NCT01981187","phase":"Phase 2","title":"LGX818 for Patients With BRAFV600 Mutated Tumors","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":12,"indication":"Solid Tumor","completionDate":"2015-09","primaryEndpoint":"The purpose of this signal seeking study is to determine whether treatment with LGX818 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warr"},{"nctId":"NCT03915951","phase":"Phase 2","title":"An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lun","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":98,"indication":"Non-small Cell Lung Cancer","completionDate":"2022-09","primaryEndpoint":"This is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in combination with binimetinib in patients with BRAFV600E-mut"},{"nctId":"NCT04657991","phase":"Phase 3","title":"A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients ","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":257,"indication":"Melanoma","completionDate":"2026-01","primaryEndpoint":"The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metas"},{"nctId":"NCT05446142","phase":"Phase 1","title":"A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":18,"indication":"Healthy","completionDate":"2022-09","primaryEndpoint":"Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations"},{"nctId":"NCT03864042","phase":"Phase 1","title":"Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":56,"indication":"Advanced Solid Tumors","completionDate":"2022-07","primaryEndpoint":"This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK)"},{"nctId":"NCT02928224","phase":"Phase 3","title":"Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":702,"indication":"BRAF V600E-mutant Metastatic Colorectal Cancer","completionDate":"2019-02","primaryEndpoint":"This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/"},{"nctId":"NCT05217446","phase":"Phase 2","title":"A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Al","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":107,"indication":"Metastatic Colorectal Cancer","completionDate":"2026-06","primaryEndpoint":"The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic"},{"nctId":"NCT01719380","phase":"Phase 2","title":"Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":156,"indication":"Colorectal Cancer","completionDate":"2015-10","primaryEndpoint":"This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer"},{"nctId":"NCT03693170","phase":"Phase 2","title":"Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal ","status":"Completed","sponsor":"Pierre Fabre Medicament","isPivotal":false,"enrollment":95,"indication":"BRAF V600E-mutant Metastatic Colorectal Cancer","completionDate":"2020-06","primaryEndpoint":"The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal ca"},{"nctId":"NCT05926960","phase":"Phase 2","title":"A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":38,"indication":"Melanoma","completionDate":"2026-02","primaryEndpoint":"The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment "},{"nctId":"NCT01909453","phase":"Phase 3","title":"Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":921,"indication":"Melanoma","completionDate":"2016-11","primaryEndpoint":"This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with loc"},{"nctId":"NCT04800822","phase":"Phase 1","title":"PF-07284892 in Participants With Advanced Solid Tumors","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":53,"indication":"Solid Tumor","completionDate":"2024-06","primaryEndpoint":"The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lor"},{"nctId":"NCT04607421","phase":"Phase 3","title":"A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreat","status":"Active Not Recruiting","sponsor":"Pfizer","isPivotal":false,"enrollment":831,"indication":"Neoplasms","completionDate":"2025-12","primaryEndpoint":"The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * ha"},{"nctId":"NCT05097599","phase":"Phase 2","title":"StrataPATH™ (Precision Indications for Approved Therapies)","status":"Terminated","sponsor":"Strata Oncology","isPivotal":false,"enrollment":11,"indication":"Cancer","completionDate":"2024-06","primaryEndpoint":"StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populati"},{"nctId":"NCT03911869","phase":"Phase 2","title":"An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":13,"indication":"Brain Metastases","completionDate":"2022-01","primaryEndpoint":"This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV6"},{"nctId":"NCT04585815","phase":"Phase 1/2","title":"Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced N","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":34,"indication":"Carcinoma, Non-Small-Cell Lung","completionDate":"2023-05","primaryEndpoint":"Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study."},{"nctId":"NCT02109653","phase":"Phase 2","title":"Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC","status":"Withdrawn","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":0,"indication":"Non-Small Cell Lung Cancer","completionDate":"2017-11","primaryEndpoint":"This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when us"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL4303479"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":7,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}