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RECRUITING
NCT07815665
PHASE2/PHASE3

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

Sponsor: Summit Therapeutics

View on ClinicalTrials.gov

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)

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-09-10

Completion Date

2030-12-31

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

Ivonescimab Dose 1

First ivonescimab dose to be tested in Phase 2

DRUG

enfortumab vedotin (EV)

Standard of care therapy

DRUG

Pembrolizumab

200 mg

DRUG

Ivonescimab Dose 2

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

DRUG

Ivonescimab 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