{"commentary":{"count":105,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":44,"youtube":32,"x_thread":27,"x_video":2},"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\": \"NCT03474107\", \"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":"NCT03474107","nct_id":"NCT03474107","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03474107. 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 received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.","label":"Arm A: Enfortumab Vedotin 1.25 mg/kg","type":"EXPERIMENTAL"},{"description":"Participants received either 75 milligrams per square meter (mg/m\\^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m\\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\\^2 paclitaxel by IV infusion over approximately 1 hour on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.","label":"Arm B: Chemotherapy","type":"ACTIVE_COMPARATOR"},{"description":"Eligible participants from chemotherapy arm who met the criteria for COE will receive 1.25 mg/kg of body weight enfortumab vedotin by intravenous infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle until discontinuation criteria is met.","label":"Cross-over Extension (COE)","type":"EXPERIMENTAL"}],"collaborators":["Seagen Inc."],"completion_date":{"date":"2025-11-27","type":"ACTUAL"},"conditions":["Ureteral Cancer","Urothelial Cancer","Bladder Cancer"],"enrollment":{"count":608,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Enfortumab Vedotin","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Vinflunine","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"}],"last_update":"2026-01-09","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-07-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months)"}],"references":[{"citation":"Rosenberg JE, Mamtani R, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Sridhar SS, Pappot H, Gurney H, Bedke J, van der Heijden MS, Galli L, Keam B, Masumori N, Meran J, O'Donnell PH, Park SH, Grande E, Sengelov L, Uemura H, Skaltsa K, Campbell M, Matsangou M, Wu C, Hepp Z, McKay C, Powles T, Petrylak DP. Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy. Eur Urol. 2024 Jun;85(6):574-585. doi: 10.1016/j.eururo.2024.01.007. Epub 2024 Feb 28.","pmid":"38418343","type":"DERIVED"},{"citation":"Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12.","pmid":"33577729","type":"DERIVED"}],"start_date":{"date":"2018-06-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)","url":"https://clinicaltrials.gov/study/NCT03474107"},"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/nct03474107"}