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A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 18 years and older * ECOG 0-1 * Life expectancy ≥ 6 months * Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component * No prior systemic therapy for LA/mUC * At least one measurable non-cerebral lesion according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Locally advanced disease that is resectable or suitable for local therapy with curative intent. * Tumors containing any small cell or neuroendocrine differentiation * Ongoing sensory or motor neuropathy Grade 2 or higher. * Radiographic findings consistent with a high risk of bleeding * History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.
About the study
A Randomized, Open-Label, Multicenter, Phase 2/3 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)
What is being tested
- Ivonescimab Dose 1 (drug)
- enfortumab vedotin (EV) (drug)
- Pembrolizumab (drug)
- Ivonescimab Dose 2 (drug)
- Ivonescimab RP3D (drug)
Sponsor: Summit Therapeutics · Participants: 800 · Started: Sep 10, 2026
Contact the study team
- Summit Clinical Trial Information · Phone: 1-833-256-0522
Official record on ClinicalTrials.gov — NCT07815665
Locations in the U.S.
| Arizona | Research Site, Phoenix (Not yet recruiting) |
| California | Research Site, Los Angeles |
| District of Columbia | Research Site, Washington D.C. (Not yet recruiting) |
| Florida | Research Site, Jacksonville (Not yet recruiting) |
| Minnesota | Research Site, Rochester (Not yet recruiting) |
| Tennessee | Research Site, Nashville (Not yet recruiting) |
| Washington | Research Site, Spokane |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.