{"preliminary_commentary":{"by_channel":{"x_thread":8,"youtube":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\": \"NCT05845814\", \"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":null,"drugs_tested":[["MK-4280A","enfortumab vedotin"],["MK-7684A","enfortumab vedotin"]],"indication":"first-line metastatic urothelial carcinoma","name":"KEYMAKER-U04","nct_id":"NCT05845814","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keymaker-u04-nct05845814. 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":"Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) as an intravenous (IV) infusion on Day 1 of every 3-week cycle for up to \\~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.","label":"Arm A: Coformulated favezelimab/pembrolizumab plus EV","type":"EXPERIMENTAL"},{"description":"Participants will receive coformulated vibostolimab/pembrolizumab (200 mg/200 mg) as an IV infusion on Day 1 of every 3-week cycle, for up to \\~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision.","label":"Arm B: Coformulated vibostolimab/pembrolizumab plus EV","type":"EXPERIMENTAL"},{"description":"Participants will receive 200 mg pembrolizumab as an IV infusion on Day 1 of every 3-week cycle for up to \\~2 years (35 cycles) and EV at 1.25 mg/kg, administered as an IV infusion on Days 1 and 8 of every 3-week cycle, until disease progression, intolerable toxicity, or investigator decision.","label":"Arm C: Pembrolizumab plus EV","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-05-31","type":"ESTIMATED"},"conditions":["Metastatic Urothelial Carcinoma","Urothelial Neoplasms"],"enrollment":{"count":390,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Coformulated favezelimab/pembrolizumab","otherNames":["MK-4280A"],"type":"BIOLOGICAL"},{"name":"Coformulated vibostolimab/pembrolizumab","otherNames":["MK-7684A"],"type":"BIOLOGICAL"},{"name":"EV","otherNames":["Padcev","ASG-22CE","ASG-22ME"],"type":"COMBINATION_PRODUCT"},{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"}],"last_update":"2025-09-10","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-05-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part 1: Objective Response Rate (ORR)","timeFrame":"Up to ~4 years"},{"measure":"Part 1: Percentage of Participants experiencing an Adverse Event (AE)","timeFrame":"Up to ~4 years"},{"measure":"Part 1: Percentage of Participants who Discontinue study interventions due to an AE","timeFrame":"Up to ~4 years"},{"measure":"Part 1: Percentage of Participants with Dose-limiting toxicities (DLT)","timeFrame":"Up to 21 days"},{"measure":"Part 2: Progression Free Survival (PFS)","timeFrame":"Up to ~4 years"}],"references":[],"start_date":{"date":"2023-06-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)","url":"https://clinicaltrials.gov/study/NCT05845814"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keymaker-u04-nct05845814"}