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)
Sponsor: Summit Therapeutics Inc.
Phase: 2, 3
Disease: Urothelial carcinoma
EU trial number: 2026-525831-17-00
Population: Adults with histologically documented, unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra, with measurable disease and ECOG performance status 0–1. Patients must not have received systemic therapy for locally advanced or metastatic disease; prior neoadjuvant or adjuvant therapy is permitted if recurrence occurred more than 12 months later.
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