NCT07815665RecruitingPhase 2/3
A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
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)
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Oct 2030
- Lead sponsor
- Summit Therapeutics
- Diseases
- Bladder cancer
- NCT number
- NCT07815665
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 800
- From Sept 2026 to the primary completion date, Oct 2030
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.
Other illness
- Locally advanced disease that is resectable or suitable for local therapy with curative intent.
- Radiographic findings consistent with a high risk of bleeding
Other
- Tumors containing any small cell or neuroendocrine differentiation
- Ongoing sensory or motor neuropathy Grade 2 or higher.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Washington D.C. | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.