{"entity":{"id":"nct07815665","kind":"trial","name":"A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma","aka":["HARMONi-GU1"],"tldr":"A phase 2/3 trial of Ivonescimab, Enfortumab vedotin and Pembrolizumab in bladder & urothelial cancer, run by Summit Therapeutics, now recruiting.","summary":"A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma is a phase 2/3 interventional study registered as NCT07815665 by Summit Therapeutics, with 800 participants planned, started 2026-09-10 and due to reach its primary completion in 2030-10-31. Interventions recorded: Ivonescimab Dose 1, enfortumab vedotin (EV), Pembrolizumab, Ivonescimab Dose 2 and Ivonescimab RP3D.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07815665","url":"https://clinicaltrials.gov/study/NCT07815665"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["adc","bispecific-antibody","checkpoint-inhibitor"],"targets":[],"drugs":["ivonescimab","enfortumab-vedotin","pembrolizumab"],"companies":["summit-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07815665","phase":"2/3","setting":"A Randomized Phase 2/3 Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)","sponsor":"Summit Therapeutics","started":"2026-09-10","startedType":"estimated","enrolled":800,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07815665/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"enfortumab-vedotin","kind":"drug","name":"Enfortumab vedotin","route":"/drugs/enfortumab-vedotin/"},{"id":"ivonescimab","kind":"drug","name":"Ivonescimab","route":"/drugs/ivonescimab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"summit-therapeutics","kind":"company","name":"Summit Therapeutics","route":"/companies/summit-therapeutics/"}]}}