A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

ClinicalTrials.gov ID: NCT07815665

Public ClinicalTrials.gov record NCT07815665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 13, 2026, 1:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT07815665
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Summit Therapeutics; Industry
Enrollment: 800 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 9, 2026
Primary completion: Oct 30, 2030
Completion: Dec 30, 2030
Last update posted: Sep 10, 2026

2026 – 2030

United States locations

U.S. sites: 7
U.S. states: 7
U.S. cities: 7

Facility	City	State	ZIP	Site status
Research Site	Phoenix	Arizona	85054	Not yet recruiting
Research Site	Los Angeles	California	90067	Recruiting
Research Site	Washington D.C.	District of Columbia	20010	Not yet recruiting
Research Site	Jacksonville	Florida	32224	Not yet recruiting
Research Site	Rochester	Minnesota	55905	Not yet recruiting
Research Site	Nashville	Tennessee	37203	Not yet recruiting
Research Site	Spokane	Washington	99208	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07815665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 10, 2026 · Synced Sep 13, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07815665 live on ClinicalTrials.gov.

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