Ivonescimab or pembrolizumab, each with enfortumab vedotin, for advanced urothelial cancer
Compares two drug combinations in adults with untreated advanced urothelial carcinoma.
Plain-language title generated from the registry record
Registry title: A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
Key facts
- Where
- Jacksonville, Los Angeles, Nashville, Phoenix, Rochester, Spokane, and Washington D.C., United StatesSee the 7 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with urothelial cancer that has spread or cannot be removed by surgery, and who have not yet had drug treatment for it.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Urothelial cancer (transitional cell carcinoma) of the bladder, renal pelvis, ureter or urethra that cannot be removed by surgery, locally advanced or metastatic, with at least 50% urothelial carcinoma component. At least one measurable tumour outside the brain.
- Earlier treatment
- No earlier drug treatment (systemic therapy) for locally advanced or metastatic disease.
Main reasons for not taking part
- Locally advanced disease that can be removed by surgery or treated locally to remove all of the disease
- Tumours with any small cell or neuroendocrine features
- Ongoing nerve damage (neuropathy) of Grade 2 or higher
- Scan findings showing a high risk of bleeding
- History of a hole in the gut wall, fistula, bowel blockage, or major bowel surgery within 6 months before the first dose
Read by machine on 9 November 2026.
Where in United States
- JacksonvilleJacksonville, United StatesNot yet recruiting
- Los AngelesLos Angeles, United StatesTaking people
- NashvilleNashville, United StatesNot yet recruiting
- PhoenixPhoenix, United StatesNot yet recruiting
- RochesterRochester, United StatesNot yet recruiting
- SpokaneSpokane, United StatesTaking people
- Washington D.C.Washington D.C., United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Summit Therapeutics
- Trial code
- NCT07815665
- Record updated
- 11 September 2026
- Original description
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)Read full original descriptionShow less
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)
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)
Inclusion: 18 years and older; ECOG 0-1; Life expectancy ≥ 6 months; Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component; No prior systemic therapy for LA/mUC; At least one measurable non-cerebral lesion according to RECIST v1.1; Adequate organ function.
Exclusion: History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose; Locally advanced disease that is resectable or suitable for local therapy with curative intent; Radiographic findings consistent with a high risk of bleeding; Tumors containing any small cell or neuroendocrine differentiation; Ongoing sensory or motor neuropathy Grade 2 or higher.