{"preliminary_commentary":{"by_channel":{"x_thread":22,"youtube":2,"podcast":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04662710\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["lenvatinib","pembrolizumab"]],"indication":"first-line advanced/metastatic gastroesophageal adenocarcinoma","name":"LEAP-015","nct_id":"NCT04662710","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=leap-015-nct04662710. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab (400 mg Q6W) plus chemotherapy (CAPOX or mFOLFOX6) will be administered for 2 cycles (approximately 12 weeks), followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab (400 mg Q6W) for 16 cycles. A cycle is 6 weeks (42 days).","label":"Lenvatinib + Pembrolizumab + Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants receive chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).","label":"Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":["Eisai Inc."],"completion_date":{"date":"2026-03-30","type":"ACTUAL"},"conditions":["Advanced/Metastatic Gastroesophageal Adenocarcinoma"],"enrollment":{"count":895,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","Keytruda®"],"type":"BIOLOGICAL"},{"name":"Lenvatinib","otherNames":["MK-7902","E7080"],"type":"BIOLOGICAL"},{"name":"Oxaliplatin","otherNames":[],"type":"DRUG"},{"name":"Capecitabine","otherNames":[],"type":"DRUG"},{"name":"Leucovorin (or Levoleucovorin)","otherNames":[],"type":"DRUG"},{"name":"5-FU","otherNames":[],"type":"DRUG"}],"last_update":"2026-04-28","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-10-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)","timeFrame":"Up to ~21 days"},{"measure":"Part 1: Number of Participants With Adverse Events (AEs)","timeFrame":"Up to ~44 months"},{"measure":"Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE","timeFrame":"Up to ~29 months"},{"measure":"Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1","timeFrame":"Up to ~41 months"},{"measure":"Part 2: OS in All Participants","timeFrame":"Up to ~41 months"},{"measure":"Part 2: 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) in Participants With PD-L1 CPS ≥1","timeFrame":"Up to ~29 months"},{"measure":"Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants","timeFrame":"Up to ~29 months"}],"references":[{"citation":"Shitara K, Lorenzen S, Li J, Bai Y, Fernandez MG, Aguilar M, Shoji H, Reyes-Cosmelli F, Pena YR, Corrales L, Wyrwicz L, Eyzaguirre DA, Pan Y, Ryu MH, Cohen DJ, Wainberg ZA, Ku G, Tabernero J, Van Cutsem E, Qin SK, Oh DY, Xu J, Liang LW, Bordia S, Bhagia P, Rha SY; LEAP-015 Investigators. Lenvatinib Plus Pembrolizumab and Chemotherapy Versus Chemotherapy in Advanced Metastatic Gastroesophageal Adenocarcinoma: The Phase III, Randomized LEAP-015 Study. J Clin Oncol. 2025 Aug;43(22):2502-2514. doi: 10.1200/JCO-25-00748. Epub 2025 May 31.","pmid":"40448579","type":"RESULT"}],"start_date":{"date":"2020-12-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)","url":"https://clinicaltrials.gov/study/NCT04662710"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/leap-015-nct04662710"}