{"commentary":{"count":19,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":8,"podcast":6,"x_thread":5},"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\": \"NCT03219333\", \"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-201","nct_id":"NCT03219333","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ev-201-nct03219333. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"EV-201","arms":[{"description":"Enfortumab vedotin on days 1, 8 and 15 every 28 days","label":"Enfortumab vedotin","type":"EXPERIMENTAL"}],"collaborators":["Seagen Inc."],"completion_date":{"date":"2023-07-28","type":"ACTUAL"},"conditions":["Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Urologic Neoplasms","Renal Pelvis Neoplasms","Urothelial Cancer","Ureteral Neoplasms","Urethral Neoplasms"],"enrollment":{"count":219,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Enfortumab vedotin","type":"DRUG"}],"last_update":"2024-08-27","lead_sponsor":"Astellas Pharma Inc","official_title":"A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2020-10-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)","timeFrame":"Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)"}],"references":[{"citation":"McGregor B, O'Donnell PH, Balar A, Petrylak D, Rosenberg J, Yu EY, Quinn DI, Heath EI, Campbell M, Hepp Z, McKay C, Steinberg J, Regnault A, Mazerolle F, Galsky MD. Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial. Eur Urol. 2022 May;81(5):515-522. doi: 10.1016/j.eururo.2022.01.032. Epub 2022 Feb 12.","pmid":"35168844","type":"DERIVED"},{"citation":"Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12.","pmid":"33991512","type":"DERIVED"},{"citation":"Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29.","pmid":"31356140","type":"DERIVED"}],"start_date":{"date":"2017-10-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT03219333"},"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-201-nct03219333"}