{"commentary":{"count":149,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":63,"podcast":45,"youtube":41},"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\": \"NCT03288545\", \"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-103","nct_id":"NCT03288545","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ev-103-nct03288545. 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-103","arms":[{"description":"Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days","label":"EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days","label":"Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days","label":"Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days","label":"Cohort D: Enfortumab Vedotin + Cisplatin in 1L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days","label":"Cohort E: Enfortumab Vedotin + Carboplatin in 1L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days","label":"Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days","label":"Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 every 21 days","label":"Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days","label":"Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 every 21 days","label":"Randomized Cohort K: Enfortumab Vedotin Monotherapy","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days","label":"Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Enfortumab vedotin on days 1 and 8 and every 21 days","label":"Cohort L: Enfortumab vedotin in MIBC in perioperative setting","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC","Seagen Inc."],"completion_date":{"date":"2026-02-20","type":"ACTUAL"},"conditions":["Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Urologic Neoplasms","Renal Pelvis Neoplasms","Urothelial Cancer","Ureteral Neoplasms","Urethral Neoplasms"],"enrollment":{"count":348,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"enfortumab vedotin (EV)","type":"DRUG"},{"name":"pembrolizumab","type":"DRUG"},{"name":"cisplatin","type":"DRUG"},{"name":"carboplatin","type":"DRUG"},{"name":"gemcitabine","type":"DRUG"}],"last_update":"2026-03-24","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer","overall_status":"TERMINATED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-02-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)","timeFrame":"Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated."},{"measure":"Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)","timeFrame":"Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated."},{"measure":"Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)","timeFrame":"Up to 3 years"},{"measure":"Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)","timeFrame":"Up to approximately 5 months"}],"references":[{"citation":"Milowsky MI, O'Donnell PH, Hoimes CJ, Petrylak DP, Flaig TW, Moon HH, Friedlander TW, Mar N, McKay RR, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret AS, Yu Y, Dillon R, Kataria R, Beaumont JL, Purnajo I, Rosenberg JE. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. J Clin Oncol. 2024 Apr 20;42(12):1403-1414. doi: 10.1200/JCO.23.01547. Epub 2024 Jan 12.","pmid":"38215355","type":"DERIVED"},{"citation":"O'Donnell PH, Milowsky MI, Petrylak DP, Hoimes CJ, Flaig TW, Mar N, Moon HH, Friedlander TW, McKay RR, Bilen MA, Srinivas S, Burgess EF, Ramamurthy C, George S, Geynisman DM, Bracarda S, Borchiellini D, Geoffrois L, Maroto Rey JP, Ferrario C, Carret AS, Yu Y, Guseva M, Homet Moreno B, Rosenberg JE. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2023 Sep 1;41(25):4107-4117. doi: 10.1200/JCO.22.02887. Epub 2023 Jun 27.","pmid":"37369081","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":"2017-10-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer","url":"https://clinicaltrials.gov/study/NCT03288545"},"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-103-nct03288545"}