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A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
Sponsor: Summit Therapeutics
Summary
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)
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2026-09-10
Completion Date
2030-12-31
Last Updated
2026-09-11
Healthy Volunteers
No
Interventions
Ivonescimab Dose 1
First ivonescimab dose to be tested in Phase 2
enfortumab vedotin (EV)
Standard of care therapy
Pembrolizumab
200 mg
Ivonescimab Dose 2
Second Ivonescimab dose to be tested in Phase 2 part of the study
Ivonescimab RP3D
Recommended Phase 3 dose of Ivonescimab after Phase 2 data analysis
Locations (7)
Research Site
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Rochester, Minnesota, United States
Research Site
Nashville, Tennessee, United States
Research Site
Spokane, Washington, United States