drugset / Trial / NCT07815665

A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

NCT07815665 ↗

Phase 2/3 Recruiting 800 enrolled Summit Therapeutics
RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start
2026-09-10
Primary completion
2030-10-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivonescimab Monoclonal antibody — —
Comparator Pembrolizumab Monoclonal antibody 200 mg —
Background Enfortumab Vedotin Other / unclassified — —

Indications