[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655581":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":59,"studyPopulation":52,"armGroups":60,"interventions":84,"overallOfficials":52,"centralContacts":106,"locations":112,"responsibleParty":182,"collaborators":52,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":52,"enrollmentInfo":194,"targetDuration":52,"studyType":197,"phases":198,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":128,"whyStopped":52,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"Summit Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":52},[9,13,16,20,23,27],{"measure":10,"description":11,"timeFrame":12},"Phase 2 Primary Outcome Measure","Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment","Through 90 days after the last study treatment",{"measure":10,"description":14,"timeFrame":15},"Number of participants with clinical laboratory abnormalities","From first dose until approximately 30 days after the last study treatment, assessed up to 3 years",{"measure":17,"description":18,"timeFrame":19},"Phase 2 Primary Outcome measure","Objective response rate (ORR)","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years",{"measure":10,"description":21,"timeFrame":22},"PK characteristics: ivonescimab serum concentration profiles","From first dose until end of treatment, assessed up to 3 years",{"measure":24,"description":25,"timeFrame":26},"Phase 3 Primary Outcome Measure","PFS per RECIST v1.1 by Independent Radiology Review Committee (IRRC)","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.",{"measure":24,"description":28,"timeFrame":29},"Overall Survival (OS)","From date of randomization until the end of study, assessed up to 4 years",[31,34,35,37,40,43,45,47,48,49],{"measure":32,"description":33,"timeFrame":19},"Phase 2 Secondary Outcome Measure","PFS per RECIST v1.1 by investigator",{"measure":32,"description":28,"timeFrame":29},{"measure":32,"description":36,"timeFrame":19},"Duration of Response (DOR)",{"measure":32,"description":38,"timeFrame":39},"Incidence of anti-drug antibodies (ADA) against ivonescimab","From time of initiation of first dose to 30 days after end of treatment.",{"measure":41,"description":42,"timeFrame":19},"Phase 3 Secondary Outcome Measure","ORR",{"measure":41,"description":44,"timeFrame":19},"DOR",{"measure":41,"description":46,"timeFrame":12},"AEs as characterized by type, incidence, severity, seriousness, and relationship to study treatment",{"measure":41,"description":14,"timeFrame":15},{"measure":41,"description":21,"timeFrame":22},{"measure":41,"description":50,"timeFrame":51},"Incidence of ADA against ivonescimab","From time of initiation of first dose to 30 days after end of treatment",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":52,"primaryPurpose":56,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":52,"whoMasked":52},"NONE","This Phase 2\u002F3 study will be conducted in 2 parts. The first part is a Phase 2 randomized, open-label, 2 dose levels, parallel-arm study with the primary objective to evaluate safety and identify the recommended Phase 3 dose (RP3D) of ivonescimab in combination with EV. The second part is a randomized, open-label Phase 3 study with the primary objective to evaluate the efficacy and safety of ivonescimab (RP3D) plus EV versus pembrolizumab plus EV in patients with previously untreated LA\u002FmUC.\n\nFor Phase 2 portion, patients will be randomized 1:1 to two arms consisting of 2 different dosages of ivonescimab.\n\n* Arm A: Ivonescimab Dose 1 + EV\n* Arm B: Ivonescimab Dose 2 + EV For Phase 3 portion, patients will be randomized 1:1 to the experimental arm (ivonescimab + EV) and the control arm (pembrolizumab + EV).\n* Arm 1 (experimental): Ivonescimab RP3D + EV\n* Arm 2 (SoC): Pembrolizumab 200 mg + EV",[61,68,73,78],{"label":62,"type":63,"description":64,"interventionNames":65},"Phase 2: Arm A","EXPERIMENTAL","Ivonescimab Dose 1 + EV",[66,67],"Drug: Ivonescimab Dose 1","Drug: enfortumab vedotin (EV)",{"label":69,"type":63,"description":70,"interventionNames":71},"Phase 2: Arm B","Ivonescimab Dose 2 + EV",[67,72],"Drug: Ivonescimab Dose 2",{"label":74,"type":63,"description":75,"interventionNames":76},"Phase 3: Arm 1","Ivonescimab RP3D (recommended Phase 3 dose) + EV",[67,77],"Drug: Ivonescimab RP3D",{"label":79,"type":80,"description":81,"interventionNames":82},"Phase 3: Arm 2","ACTIVE_COMPARATOR","Pembrolizumab 200 mg + EV",[67,83],"Drug: Pembrolizumab",[85,90,94,98,102],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":52},"DRUG","Ivonescimab Dose 1","First ivonescimab dose to be tested in Phase 2",[62],{"type":86,"name":91,"description":92,"armGroupLabels":93,"otherNames":52},"enfortumab vedotin (EV)","Standard of care therapy",[62,69,74,79],{"type":86,"name":95,"description":96,"armGroupLabels":97,"otherNames":52},"Pembrolizumab","200 mg",[79],{"type":86,"name":99,"description":100,"armGroupLabels":101,"otherNames":52},"Ivonescimab Dose 2","Second Ivonescimab dose to be tested in Phase 2 part of the study",[69],{"type":86,"name":103,"description":104,"armGroupLabels":105,"otherNames":52},"Ivonescimab RP3D","Recommended Phase 3 dose of Ivonescimab after Phase 2 data analysis",[74],[107],{"name":108,"role":109,"phone":110,"phoneExt":52,"email":111},"Summit Clinical Trial Information","CONTACT","1-833-256-0522","medicalinformation@smmttx.com",[113,127,137,146,155,164,173],{"facility":114,"status":115,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":52},"Research Site","NOT_YET_RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":122,"coordinates":123},"Point",[124,125],-112.07404,33.44838,{"lat":125,"lon":124},{"facility":114,"status":128,"city":129,"state":130,"zip":131,"country":119,"countryCode":120,"cosmosGeoPoint":132,"geoPoint":136,"contacts":52},"RECRUITING","Los Angeles","California","90067",{"type":122,"coordinates":133},[134,135],-118.24368,34.05223,{"lat":135,"lon":134},{"facility":114,"status":115,"city":138,"state":139,"zip":140,"country":119,"countryCode":120,"cosmosGeoPoint":141,"geoPoint":145,"contacts":52},"Washington D.C.","District of Columbia","20010",{"type":122,"coordinates":142},[143,144],-77.03637,38.89511,{"lat":144,"lon":143},{"facility":114,"status":115,"city":147,"state":148,"zip":149,"country":119,"countryCode":120,"cosmosGeoPoint":150,"geoPoint":154,"contacts":52},"Jacksonville","Florida","32224",{"type":122,"coordinates":151},[152,153],-81.65565,30.33218,{"lat":153,"lon":152},{"facility":114,"status":115,"city":156,"state":157,"zip":158,"country":119,"countryCode":120,"cosmosGeoPoint":159,"geoPoint":163,"contacts":52},"Rochester","Minnesota","55905",{"type":122,"coordinates":160},[161,162],-92.4699,44.02163,{"lat":162,"lon":161},{"facility":114,"status":115,"city":165,"state":166,"zip":167,"country":119,"countryCode":120,"cosmosGeoPoint":168,"geoPoint":172,"contacts":52},"Nashville","Tennessee","37203",{"type":122,"coordinates":169},[170,171],-86.78444,36.16589,{"lat":171,"lon":170},{"facility":114,"status":128,"city":174,"state":175,"zip":176,"country":119,"countryCode":120,"cosmosGeoPoint":177,"geoPoint":181,"contacts":52},"Spokane","Washington","99208",{"type":122,"coordinates":178},[179,180],-117.42908,47.65966,{"lat":180,"lon":179},{"type":183,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","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":195,"type":196},800,"ESTIMATED","INTERVENTIONAL",[199,200],"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)",[203,204],"Metastatic Urothelial Carcinoma","Metastatic Urothelial Carcinoma (UC)",[206,207],"LA\u002FmUC","Ivonescimab","2026-09-08",{"date":210,"type":211},"2026-09-11","ACTUAL",{"date":213,"type":196},"2026-09-10",{"date":215,"type":196},"2030-12-31",{"name":5,"class":6},7]