NCT07815665 A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
| NCT ID | NCT07815665 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Summit Therapeutics |
| Condition | Metastatic Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2026-09-10 |
| Primary Completion | 2030-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 800 participants in total. It began in 2026-09-10 with a primary completion date of 2030-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Locally advanced disease that is resectable or suitable for local therapy with curative intent. * Tumors containing any small cell or neuroendocrine differentiation * Ongoing sensory or motor neuropathy Grade 2 or higher. * Radiographic findings consistent with a high risk of bleeding * History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07815665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07815665 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07815665 currently recruiting?
Yes, NCT07815665 is actively recruiting participants. Contact the research team at medicalinformation@smmttx.com for enrollment information.
Where is the NCT07815665 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Washington D.C., United States, Jacksonville, United States and 3 additional locations.
Who is sponsoring the NCT07815665 clinical trial?
NCT07815665 is sponsored by Summit Therapeutics. The trial plans to enroll 800 participants.