[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-urothelial-carcinoma-uc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-urothelial-carcinoma-uc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100655581","phase-2-a-study-of-ivonescimab-in-combination-with-enfortumab-vedotin-vs-pembrolizumab-in-combination-with-enfortumab-vedotin-in-metastatic-urothelial-carcinoma-100655581",false,"NCT07815665","A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma","A Randomized Phase 2\u002F3 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)","HARMONi-GU1","Inclusion Criteria:\n\n* 18 years and older\n* ECOG 0-1\n* Life expectancy ≥ 6 months\n* Histologically documented unresectable LA\u002FmUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component\n* No prior systemic therapy for LA\u002FmUC\n* At least one measurable non-cerebral lesion according to RECIST v1.1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Locally advanced disease that is resectable or suitable for local therapy with curative intent.\n* Tumors containing any small cell or neuroendocrine differentiation\n* Ongoing sensory or motor neuropathy Grade 2 or higher.\n* Radiographic findings consistent with a high risk of bleeding\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.","ALL","18 Years",{"count":20,"type":21},800,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","A Randomized, Open-Label, Multicenter, Phase 2\u002F3 Clinical 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)",[28,29],"Metastatic Urothelial Carcinoma","Metastatic Urothelial Carcinoma (UC)",[31,32],"LA\u002FmUC","Ivonescimab","RECRUITING","2026-09-08",{"date":36,"type":37},"2026-09-11","ACTUAL",{"date":39,"type":21},"2026-09-10",{"date":41,"type":21},"2030-12-31",{"name":43,"class":44},"Summit Therapeutics","INDUSTRY",7]