{"commentary":{"count":853,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":454,"youtube":203,"podcast":186,"x_video":10},"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\": \"NCT04223856\", \"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":"EV-302","nct_id":"NCT04223856","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ev-302-nct04223856. 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":"EV-302","arms":[{"description":"Enfortumab vedotin + pembrolizumab","label":"Arm A","type":"EXPERIMENTAL"},{"description":"Gemcitabine + cisplatin or carboplatin","label":"Arm B","type":"ACTIVE_COMPARATOR"}],"collaborators":["Merck Sharp & Dohme LLC","Seagen Inc."],"completion_date":{"date":"2028-03-01","type":"ESTIMATED"},"conditions":["Urothelial Cancer"],"enrollment":{"count":886,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Enfortumab vedotin","type":"DRUG"},{"name":"Pembrolizumab","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"}],"last_update":"2026-05-29","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-08-08","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)","timeFrame":"From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)"},{"measure":"Overall Survival (OS)","timeFrame":"From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)"}],"references":[{"citation":"Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Homet Moreno B, Beaumont JL, Purnajo I, McManus S, Powles T. How enfortumab vedotin plus pembrolizumab affects the quality of life of people with advanced urothelial cancer compared with platinum-based chemotherapy: a plain language summary of patient-reported outcomes from the EV-302 study. Future Oncol. 2026 Apr;22(9):1015-1029. doi: 10.1080/14796694.2026.2645984. Epub 2026 Apr 2.","pmid":"41925239","type":"DERIVED"},{"citation":"Kikuchi E, Van der Heijden MS, Valderrama BP, Gupta S, Bedke J, Shin SJ, Li JR, Guo J, Danchaivijitr P, Kanesvaran R, Park SH, Su WP, Kandori S, Bae WK, Wong A, Gorla S, Bavle A, Yu X, Lu YT, Powles T. Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma. Int J Clin Oncol. 2026 Mar;31(3):436-446. doi: 10.1007/s10147-025-02950-8. Epub 2026 Jan 21.","pmid":"41563650","type":"DERIVED"},{"citation":"Meng Y, Zhang S, Aout M, Babcock A, Li H, Lai Y, Brand-Wiita S, Notinger S, Bavle A, Mamtani R. Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. J Med Econ. 2025 Dec;28(1):1779-1797. doi: 10.1080/13696998.2025.2567190. Epub 2025 Oct 14.","pmid":"41039930","type":"DERIVED"},{"citation":"Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Moreno BH, Beaumont JL, Purnajo I, McManus S, Powles T. Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2025 Jun;26(6):795-805. doi: 10.1016/S1470-2045(25)00158-5.","pmid":"40449498","type":"DERIVED"},{"citation":"Benjamin DJ, Rezazadeh Kalebasty A, Prasad V. The Overall Survival Benefit in EV-302: Is Enfortumab Vedotin plus Pembrolizumab the New Frontline Standard of Care for Metastatic Urothelial Carcinoma? Eur Urol Oncol. 2024 Jun;7(3):313-315. doi: 10.1016/j.euo.2024.02.010. Epub 2024 Mar 13.","pmid":"38485615","type":"DERIVED"},{"citation":"Niegisch G. Enfortumab Vedotin and Pembrolizumab - A New Perspective on Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):944-946. doi: 10.1056/NEJMe2400311. No abstract available.","pmid":"38446680","type":"DERIVED"},{"citation":"Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gumus M, Mar N, Loriot Y, Flechon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117.","pmid":"38446675","type":"DERIVED"},{"citation":"Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30.","pmid":"36041086","type":"DERIVED"}],"start_date":{"date":"2020-03-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer","url":"https://clinicaltrials.gov/study/NCT04223856"},"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/ev-302-nct04223856"}