{"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,"name":"INTerpath-005","nct_id":"NCT06305767","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=interpath-005-nct06305767. 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":"Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of intismeran autogene. Intismeran autogene doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.","label":"Adjuvant Cohort: Pembrolizumab + Intismeran autogene","type":"EXPERIMENTAL"},{"description":"Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of placebo. Placebo doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.","label":"Adjuvant Cohort: Pembrolizumab + Placebo","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive neoadjuvant treatment with up to 4 cycles of pembrolizumab plus EV and 1 to 4 doses of intismeran autogene, followed by radical cystectomy \\[RC\\] plus pelvic lymph node dissection \\[PLND\\], and then adjuvant treatment with up to 13 cycles of pembrolizumab plus up to 5 cycles of EV and 5 to 8 doses of intismeran autogene (for a total of 9 neoadjuvant plus adjuvant Intismeran autogene doses), or until any of the protocol-specified criteria for discontinuation of study intervention are met. The total duration of treatment is up to approximately 16 months.","label":"Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery","type":"EXPERIMENTAL"}],"collaborators":["ModernaTX, Inc."],"completion_date":{"date":"2031-10-20","type":"ESTIMATED"},"conditions":["Bladder Cancer"],"enrollment":{"count":230,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","Keytruda®"],"type":"BIOLOGICAL"},{"name":"Intismeran autogene","otherNames":["V940"],"type":"BIOLOGICAL"},{"name":"Placebo","otherNames":[],"type":"OTHER"},{"name":"Enfortumab Vedotin","otherNames":["PADCEV®"],"type":"BIOLOGICAL"},{"name":"Surgery (RC plus PLND)","otherNames":[],"type":"PROCEDURE"}],"last_update":"2026-01-13","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-04-23","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Adjuvant Cohort: Disease Free Survival (DFS)","timeFrame":"Up to approximately 28 months"},{"measure":"Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE)","timeFrame":"Up to approximately 19 months"},{"measure":"Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE","timeFrame":"Up to approximately 16 months"}],"references":[],"start_date":{"date":"2024-03-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)","url":"https://clinicaltrials.gov/study/NCT06305767"},"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/interpath-005-nct06305767"}