{"preliminary_commentary":{"by_channel":{"youtube":34,"podcast":34,"x_thread":7,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03517449\", \"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."},"name":"NCT03517449","nct_id":"NCT03517449","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03517449. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.","label":"Lenvatinib 20 mg + Pembrolizumab 200 mg","type":"EXPERIMENTAL"},{"description":"Participants will receive either of the following treatments: doxorubicin 60 milligram per square meter (mg/m\\^2) administered by IV on Day 1 of each 21-day cycle for up to a maximum cumulative dose of 500 mg/m\\^2 OR paclitaxel 80 mg/m\\^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.","label":"Treatment of Physician's Choice","type":"ACTIVE_COMPARATOR"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2025-02-26","type":"ACTUAL"},"conditions":["Endometrial Neoplasms"],"enrollment":{"count":827,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["KEYTRUDA®","MK-3475"],"type":"DRUG"},{"name":"Lenvatinib","otherNames":["LENVIMA®"],"type":"DRUG"},{"name":"Paclitaxel","otherNames":["TAXOL®"],"type":"DRUG"},{"name":"Doxorubicin","otherNames":["ADRIAMYCIN®"],"type":"DRUG"}],"last_update":"2026-03-19","lead_sponsor":"Eisai Inc.","official_title":"A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-03-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants","timeFrame":"Up to approximately 27 months"},{"measure":"PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants","timeFrame":"Up to approximately 27 months"},{"measure":"Overall Survival (OS) in pMMR Participants","timeFrame":"Up to approximately 43 months"},{"measure":"OS in All-comer Participants","timeFrame":"Up to approximately 43 months"}],"references":[{"citation":"Marth C, Lorusso D, Bidzinski M, Scollo P, Vardar MA, Oaknin A, Kaen DL, Nogueira-Rodrigues A, Miller DS, Hasegawa K, MacKay H, Moore RG, Santin AD, Yunokawa M, Romero I, Pignata S, Baron-Hay S, Kim YM, Amit A, Ghamande S, Danska-Bidzinska A, Tarnawski R, Wang PH, Yu Z, Slomovitz BM, Okpara CE, McKenzie J, Meng R, Orlowski R, Makker V. Lenvatinib plus pembrolizumab in participants with advanced or recurrent endometrial cancer: Study 309/KEYNOTE-775 and ENGOT-en9/LEAP-001 post-(neo)adjuvant therapy outcomes. Int J Gynecol Cancer. 2026 Jul;36(7):104693. doi: 10.1016/j.ijgc.2026.104693. Epub 2026 Apr 12.","pmid":"42167105","type":"DERIVED"},{"citation":"Yonemori K, Fujiwara K, Hasegawa K, Yunokawa M, Ushijima K, Suzuki S, Shikama A, Minobe S, Usami T, Kim JW, Kim BG, Wang PH, Chang TC, Yamamoto K, Han S, McKenzie J, Orlowski RJ, Miura T, Makker V, Man Kim Y. Analysis of East Asia subgroup in Study 309/KEYNOTE-775: lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer. J Gynecol Oncol. 2024 Mar;35(2):e40. doi: 10.3802/jgo.2024.35.e40. Epub 2024 Jan 19.","pmid":"38302725","type":"DERIVED"},{"citation":"Colombo N, Lorusso D, Monk BJ, Slomovitz B, Hasegawa K, Nogueira-Rodrigues A, Zale M, Okpara CE, Barresi G, McKenzie J, Makker V. Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab. Oncologist. 2024 Jan 5;29(1):25-35. doi: 10.1093/oncolo/oyad201.","pmid":"37523661","type":"DERIVED"},{"citation":"Lorusso D, Colombo N, Herraez AC, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay SE, Ray-Coquard IL, Shapira-Frommer R, Kim YM, McCormack M, Massaad R, Nguyen AM, Zhao Q, McKenzie J, Prabhu VS, Makker V. Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician's Choice. Eur J Cancer. 2023 Jun;186:172-184. doi: 10.1016/j.ejca.2023.03.015. Epub 2023 Mar 23.","pmid":"37086595","type":"DERIVED"},{"citation":"Makker V, Colombo N, Casado Herraez A, Monk BJ, Mackay H, Santin AD, Miller DS, Moore RG, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim YM, Guerra Alia EM, Sanli UA, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, Lorusso D. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775. J Clin Oncol. 2023 Jun 1;41(16):2904-2910. doi: 10.1200/JCO.22.02152. Epub 2023 Apr 14.","pmid":"37058687","type":"DERIVED"},{"citation":"Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19.","pmid":"35045221","type":"DERIVED"}],"start_date":{"date":"2018-06-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])","url":"https://clinicaltrials.gov/study/NCT03517449"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03517449"}