{"commentary":{"count":58,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":30,"podcast":16,"youtube":12},"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\": \"NCT03713593\", \"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":"NCT03713593","nct_id":"NCT03713593","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03713593. 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 receive lenvatinib 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 (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.","label":"lenvatinib plus pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \\<60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.","label":"lenvatinib plus placebo","type":"ACTIVE_COMPARATOR"}],"collaborators":["Eisai Inc."],"completion_date":{"date":"2024-09-24","type":"ACTUAL"},"conditions":["Carcinoma, Hepatocellular"],"enrollment":{"count":794,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"lenvatinib","type":"DRUG"},{"name":"pembrolizumab","type":"BIOLOGICAL"},{"name":"saline placebo","type":"DRUG"}],"last_update":"2026-02-05","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) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-06-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","timeFrame":"Up to approximately 41 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 41 months"}],"references":[{"citation":"Llovet JM, Kudo M, Merle P, Meyer T, Qin S, Ikeda M, Xu R, Edeline J, Ryoo BY, Ren Z, Masi G, Kwiatkowski M, Lim HY, Kim JH, Breder V, Kumada H, Cheng AL, Galle PR, Kaneko S, Wang A, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS; LEAP-002 Investigators. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1399-1410. doi: 10.1016/S1470-2045(23)00469-2.","pmid":"38039993","type":"RESULT"}],"start_date":{"date":"2018-12-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)","url":"https://clinicaltrials.gov/study/NCT03713593"},"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/nct03713593"}