Search > Urothelial Carcinoma
800 Participants NeededMy employer runs this trial

Ivonescimab + Enfortumab Vedotin vs Pembrolizumab for Urothelial Carcinoma

(HARMONi-GU1 Trial)

Recruiting at 6 trial locations
SC
Overseen BySummit Clinical Trial Information
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Summit Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Are You a Good Fit for This Trial?

This trial is for adults with locally advanced or metastatic urothelial (transitional cell) carcinoma who have not received prior treatment for their advanced cancer. Participants should be in generally good health aside from their cancer.

Inclusion Criteria

I have not had any systemic treatment for advanced urothelial cancer.
Life expectancy of 6 months or more
My organs are working well enough for treatment.
See 4 more

Exclusion Criteria

I have had serious bowel issues or surgery in the past 6 months.
Radiographic findings consistent with a high risk of bleeding
My cancer can be removed or treated locally with the goal of a cure.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Enfortumab Vedotin
  • Ivonescimab
  • Pembrolizumab

Trial Overview

The study compares two treatments: one group gets Ivonescimab plus Enfortumab Vedotin, and the other gets Pembrolizumab plus Enfortumab Vedotin. Patients are randomly assigned to each group to see which combination works better.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Phase 3: Arm 1Experimental Treatment2 Interventions
Group II: Phase 2: Arm BExperimental Treatment2 Interventions
Group III: Phase 2: Arm AExperimental Treatment2 Interventions
Group IV: Phase 3: Arm 2Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Summit Therapeutics

Lead Sponsor

Trials
18
Recruited
4,500+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.