{"preliminary_commentary":{"by_channel":{"x_thread":4,"podcast":1},"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":false},"commentary_summary":null,"name":"HCRN GU22-598","nct_id":"NCT06809140","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=hcrn-gu22-598-nct06809140. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) plus pembrolizumab (200 mg) followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (defined below) will receive 14 cycles of \"maintenance\" treatment. Enfortumab vedotin (1.25 mg/kg for a maximum dose of 125 mg) will be administered during the first 6 cycles (C4-C9) of \"maintenance\" treatment and pembrolizumab (200 mg) will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \\>cTa disease) will undergo cystectomy.","label":"Enfortumab vedotin plus pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":["Seagen Inc.","Astellas Pharma Inc","Merck Sharp & Dohme LLC","Icahn School of Medicine at Mount Sinai"],"completion_date":{"date":"2029-11","type":"ESTIMATED"},"conditions":["Muscle Invasive Bladder Urothelial Carcinoma"],"enrollment":{"count":75,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Enfortumab vedotin","otherNames":[],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":[],"type":"DRUG"}],"last_update":"2026-08-05","lead_sponsor":"Matthew Galsky","official_title":"Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-11","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Complete response rate with enfortumab vedotin plus pembrolizumab for MIBC","timeFrame":"9 weeks"},{"measure":"Bladder-intact event-free survival (BIEFS) in patients achieving a clinical complete response","timeFrame":"2 years"}],"references":[],"start_date":{"date":"2025-04-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT06809140"},"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/hcrn-gu22-598-nct06809140"}