{"preliminary_commentary":{"by_channel":{"x_thread":3},"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,"drugs_tested":null,"indication":null,"name":"TROPION-Urothelial04","nct_id":"NCT07720284","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tropion-urothelial04-nct07720284. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TU-04","arms":[{"description":"Dato-DXd: 6 mg/kg IV Q3W for 9 cycles (approximately 6 months), can be extended based on Investigator assessment of tolerability up to 17 cycles or up to 1 year + rilvegostomig: 750 mg IV Q3W 17 cycles or up to 1 year whichever occurs first.","label":"Arm 1: Dato-DXd + rilvegostomig","type":"EXPERIMENTAL"},{"description":"Dato-DXd: 6 mg/kg IV Q3W for 9 cycles (approximately 6 months), can be extended based on Investigator assessment of tolerability up to 17 cycles or up to 1 year.","label":"Arm 2: Dato-DXd monotherapy","type":"EXPERIMENTAL"},{"description":"Either: Nivolumab: 240 mg IV Q2W OR 480 mg IV Q4W up to 1 year\n\nOr: Durvalumab: 1500 mg IV Q4W for 8 cycles (or at a dose of 20 mg/kg Q4W in participants who weigh ≤ 30 kg)\n\nOr: EV 1.25 mg/kg D1, D8 Q3W up to 6 cycles + pembrolizumab 200 mg IV Q3W up to 14 cycles or 400 mg IV Q6W up to 7 cycles.","label":"Arm 3 (SoC): nivolumab or durvalumab or EV + pembrolizumab","type":"ACTIVE_COMPARATOR"}],"collaborators":["Daiichi Sankyo"],"completion_date":{"date":"2032-11-23","type":"ESTIMATED"},"conditions":["High-risk Muscle Invasive Urothelial Carcinoma"],"enrollment":{"count":915,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Dato-DXd","otherNames":["Datopotamab deruxtecan","(Dato-DXd, DS-1062a)"],"type":"DRUG"},{"name":"Rilvegostomig","otherNames":["AZD2936"],"type":"DRUG"},{"name":"Durvalumab","otherNames":["Imfinzi, MEDI4736"],"type":"DRUG"},{"name":"Nivolumab","otherNames":["OPDIVO®, BMS-936558"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["Keytruda, MK-3475"],"type":"DRUG"},{"name":"Enfortumab vedotin","otherNames":["Padcev®, ASG-22CE, AGS-22M6E"],"type":"DRUG"}],"last_update":"2026-07-22","lead_sponsor":"AstraZeneca","official_title":"A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2030-09-11","type":"ESTIMATED"},"primary_outcomes":[{"measure":"To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of disease-free survival (DFS) (based on Investigator assessments).","timeFrame":"From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in)."}],"references":[],"start_date":{"date":"2026-07-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC","url":"https://clinicaltrials.gov/study/NCT07720284"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.3","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tropion-urothelial04-nct07720284"}