{"commentary":{"count":14,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":11,"youtube":2,"podcast":1},"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\": \"NCT03898180\", \"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":"NCT03898180","nct_id":"NCT03898180","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03898180. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib.","label":"Pembrolizumab + Lenvatinib","type":"EXPERIMENTAL"},{"description":"Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo.","label":"Pembrolizumab + Placebo","type":"ACTIVE_COMPARATOR"}],"collaborators":["Eisai Inc."],"completion_date":{"date":"2024-05-20","type":"ACTUAL"},"conditions":["Urothelial Carcinoma"],"enrollment":{"count":505,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Lenvatinib","type":"DRUG"},{"name":"Placebo for lenvatinib","type":"DRUG"}],"last_update":"2026-02-05","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-07-26","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Up to approximately 25 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 25 months"}],"references":[{"citation":"Matsubara N, de Wit R, Balar AV, Siefker-Radtke AO, Zolnierek J, Csoszi T, Shin SJ, Park SH, Atduev V, Gumus M, Su YL, Karaca SB, Cutuli HJ, Sendur MAN, Shen L, O'Hara K, Okpara CE, Franco S, Moreno BH, Grivas P, Loriot Y. Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial. Eur Urol. 2024 Mar;85(3):229-238. doi: 10.1016/j.eururo.2023.08.012. Epub 2023 Sep 29.","pmid":"37778952","type":"RESULT"},{"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"}],"start_date":{"date":"2019-05-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)","url":"https://clinicaltrials.gov/study/NCT03898180"},"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/nct03898180"}