OncoMatch/Clinical Trials/NCT07815665
A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
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)
Is NCT07815665 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2/3 trial studies multiple treatments for metastatic urothelial carcinoma.
Treatment: Ivonescimab Dose 1 · enfortumab vedotin (EV) · Pembrolizumab · Ivonescimab Dose 2 · Ivonescimab RP3D — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Phoenix, Arizona
- Research Site · Los Angeles, California
- Research Site · Washington D.C., District of Columbia
- Research Site · Jacksonville, Florida
- Research Site · Rochester, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07815665 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages