{"preliminary_commentary":{"by_channel":{"x_thread":48,"podcast":44,"youtube":40,"x_video":3,"bluesky_thread":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\": \"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 free public preview; the full report is still bought."},"commentary_summary":{"generated_at":"2026-10-29T03:06:51.801Z","note":"Automated, Oct 29, 2026. Not an Erudio report: no source links. Not medical advice.","passages_read":null,"text":"Discussion covers post-hoc analyses of enfortumab vedotin exposure and dose modification, including the relationship between early exposure, response, and subsequent dose reductions or holds. It considers whether starting-dose intensity and later changes in exposure may influence outcomes, and examines dose-related analyses in EV-301. Commentary also addresses health-related quality-of-life domains, including pain, appetite, and neuropathy, and raises the need for predictive biomarkers such as NECTIN4."},"name":"EV-301","nct_id":"NCT03474107","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ev-301-nct03474107. 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 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","otherNames":["ASG-22ME","ASG-22CE"],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"},{"name":"Vinflunine","otherNames":[],"type":"DRUG"},{"name":"Paclitaxel","otherNames":[],"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":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ev-301-nct03474107"}