{"commentary":{"count":121,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":61,"youtube":29,"podcast":28,"x_video":3},"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\": \"NCT04246177\", \"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":"NCT04246177","nct_id":"NCT04246177","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04246177. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \\<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \\[\\~35 cycles\\] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).","label":"Lenvatinib plus Pembrolizumab plus TACE","type":"EXPERIMENTAL"},{"description":"Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (\\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).","label":"Oral Placebo plus IV Placebo plus TACE","type":"ACTIVE_COMPARATOR"}],"collaborators":["Eisai Inc."],"completion_date":{"date":"2026-03-26","type":"ACTUAL"},"conditions":["Carcinoma, Hepatocellular"],"enrollment":{"count":480,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Lenvatinib","type":"DRUG"},{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Oral Placebo","type":"DRUG"},{"name":"IV Placebo","type":"DRUG"},{"name":"TACE","type":"PROCEDURE"}],"last_update":"2026-09-03","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2025-08-19","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","timeFrame":"Up to approximately 43.5 Months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 61.7 Months"}],"references":[{"citation":"Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8.","pmid":"39798578","type":"RESULT"},{"citation":"Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.","pmid":"35421228","type":"DERIVED"},{"citation":"Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. Cardiovasc Intervent Radiol. 2022 Apr;45(4):405-412. doi: 10.1007/s00270-021-03031-9. Epub 2022 Feb 4.","pmid":"35119481","type":"DERIVED"},{"citation":"Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.","pmid":"33300372","type":"DERIVED"},{"citation":"Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.","pmid":"32557715","type":"DERIVED"}],"start_date":{"date":"2020-05-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)","url":"https://clinicaltrials.gov/study/NCT04246177"},"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/nct04246177"}