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

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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