{"commentary":{"count":9,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":5,"podcast":4},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02928224\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"BEACON CRC","nct_id":"NCT02928224","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=beacon-crc-nct02928224. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"BEACON CRC","arms":[{"description":"Encorafenib + binimetinib + cetuximab.","label":"Safety Lead-in, Triplet Arm","type":"EXPERIMENTAL"},{"description":"Encorafenib + cetuximab.","label":"Doublet Arm","type":"EXPERIMENTAL"},{"description":"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.","label":"Control Arm","type":"ACTIVE_COMPARATOR"}],"collaborators":["Merck KGaA, Darmstadt, Germany","Pierre Fabre Medicament","Ono Pharmaceutical Co., Ltd."],"completion_date":{"date":"2022-11-10","type":"ACTUAL"},"conditions":["BRAF V600E-mutant Metastatic Colorectal Cancer"],"enrollment":{"count":702,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Encorafenib","type":"DRUG"},{"name":"Binimetinib","type":"DRUG"},{"name":"Cetuximab","type":"DRUG"},{"name":"Irinotecan","type":"DRUG"},{"name":"Folinic Acid","type":"DRUG"},{"name":"5-Fluorouracil","type":"DRUG"}],"last_update":"2023-12-21","lead_sponsor":"Pfizer","official_title":"A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-02-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"(Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)","timeFrame":"Cycle 1 (up to 28 days)"},{"measure":"(Safety Lead-in) Number of Participants With Adverse Events (AEs)","timeFrame":"Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)"},{"measure":"(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis","timeFrame":"Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)"},{"measure":"(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis","timeFrame":"From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)"},{"measure":"(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis","timeFrame":"From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm)"},{"measure":"(Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm","timeFrame":"Duration of Phase 3, approximately 6 months (up to 28 days per cycle)"}],"references":[{"citation":"Kopetz S, Murphy DA, Pu J, Ciardiello F, Desai J, Van Cutsem E, Wasan HS, Yoshino T, Saffari H, Zhang X, Hamilton P, Xie T, Yaeger R, Tabernero J. Molecular profiling of BRAF-V600E-mutant metastatic colorectal cancer in the phase 3 BEACON CRC trial. Nat Med. 2024 Nov;30(11):3261-3271. doi: 10.1038/s41591-024-03235-9. Epub 2024 Sep 23.","pmid":"39313594","type":"DERIVED"},{"citation":"Taieb J, Lonardi S, Desai J, Folprecht G, Gallois C, Marques EP, Khan S, Castagne C, Wasan H. Adverse Events Associated with Encorafenib Plus Cetuximab in Patients with BRAFV600E-mutant Metastatic Colorectal Cancer: An in-depth Analysis of the BEACON CRC Study. Clin Colorectal Cancer. 2023 Mar;22(1):59-66. doi: 10.1016/j.clcc.2022.12.003. Epub 2022 Dec 24.","pmid":"36653241","type":"DERIVED"},{"citation":"Stintzing S, Seufferlein T, Rose C, Reichenbach F, Luftner D. Encorafenib in Combination With Cetuximab After Systemic Therapy in Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: German Health Technology Assessment-Driven Analyses From the BEACON CRC Study. Clin Colorectal Cancer. 2022 Sep;21(3):244-251. doi: 10.1016/j.clcc.2022.04.002. Epub 2022 May 5.","pmid":"35654691","type":"DERIVED"},{"citation":"Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. doi: 10.1016/j.esmoop.2022.100477. Epub 2022 May 30.","pmid":"35653981","type":"DERIVED"},{"citation":"Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.","pmid":"33503393","type":"DERIVED"},{"citation":"Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. doi: 10.1056/NEJMoa1908075. Epub 2019 Sep 30.","pmid":"31566309","type":"DERIVED"},{"citation":"Van Cutsem E, Huijberts S, Grothey A, Yaeger R, Cuyle PJ, Elez E, Fakih M, Montagut C, Peeters M, Yoshino T, Wasan H, Desai J, Ciardiello F, Gollerkeri A, Christy-Bittel J, Maharry K, Sandor V, Schellens JHM, Kopetz S, Tabernero J. Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study. J Clin Oncol. 2019 Jun 10;37(17):1460-1469. doi: 10.1200/JCO.18.02459. Epub 2019 Mar 20.","pmid":"30892987","type":"DERIVED"}],"start_date":{"date":"2016-10-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer","url":"https://clinicaltrials.gov/study/NCT02928224"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/beacon-crc-nct02928224"}