RecruitingPhase 2Phase 3NCT07815665

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)

Sponsor

Summit Therapeutics

Enrollment

800 participants

Start Date

Sep 10, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Urothelial Carcinoma Metastatic Urothelial Carcinoma (UC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ivonescimab Dose 1, a drug called Ivonescimab Dose 2, and others for people with metastatic urothelial carcinoma and metastatic urothelial carcinoma (uc). The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvonescimab Dose 1

First ivonescimab dose to be tested in Phase 2

DRUGenfortumab vedotin (EV)

Standard of care therapy

DRUGPembrolizumab

200 mg

DRUGIvonescimab Dose 2

Second Ivonescimab dose to be tested in Phase 2 part of the study

DRUGIvonescimab RP3D

Recommended Phase 3 dose of Ivonescimab after Phase 2 data analysis

Locations(7)

Research Site

Phoenix, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Jacksonville, Florida, United States

Research Site

Rochester, Minnesota, United States

Research Site

Nashville, Tennessee, United States

Research Site

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07815665

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