A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
NCT07815665 · HARMONi-GU1 Phase 2/3Recruiting
- Lead sponsor
- Summit Therapeutics (Industry)
- Enrollment
- 800 (estimated)
- Start date
- 10 Sep 2026
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030
- Last update posted
- 11 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 4
Interventions
- Ivonescimab Dose 1 Drug
- enfortumab vedotin (EV) Drug
- Pembrolizumab Drug
- Ivonescimab Dose 2 Drug
- Ivonescimab RP3D Drug
Conditions and primary outcome
- Metastatic Urothelial Carcinoma
- Metastatic Urothelial Carcinoma (UC)
Primary outcome
Phase 2 Primary Outcome Measure (Through 90 days after the last study treatment); Phase 2 Primary Outcome Measure (From first dose until approximately 30 days after the last study treatment, assessed up to 3 years); Phase 2 Primary Outcome measure (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years); Phase 2 Primary Outcome Measure (From first dose until end of treatment, assessed up to 3 years); Phase 3 Primary Outcome Measure (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.); Phase 3 Primary Outcome Measure (From date of randomization until the end of study, assessed up to 4 years)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07815665.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07815665 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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