Ivonescimab plus enfortumab vedotin vs pembrolizumab plus enfortumab vedotin in untreated locally advanced or metastatic urothelial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part Phase 2/3 randomized, open-label study evaluating an ivonescimab and enfortumab vedotin combination versus pembrolizumab and enfortumab vedotin in patients with previously untreated, unresectable locally advanced or metastatic urothelial carcinoma. Part 1 identifies the recommended Phase 3 dose of ivonescimab in combination with EV using two dosage levels. Part 2 compares the efficacy and safety of the ivonescimab plus EV regimen against pembrolizumab plus EV. Eligible adults are ECOG 0-1 with measurable disease and adequate organ function; key exclusions include resectable disease with curative potential and certain GI conditions. The study will be conducted at multiple sites in the U.S. and is led by Summit Therapeutics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Spokane, Washington, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Not yet recruiting
• Research Site
  Washington D.C., District of Columbia, United States Not yet recruiting
• Research Site
  Jacksonville, Florida, United States Not yet recruiting
• Research Site
  Rochester, Minnesota, United States Not yet recruiting

Study contacts

• Study coordinator: Summit Clinical Trial Information
• Email: medicalinformation@smmttx.com
• Phone: 1-833-256-0522

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• Enfortumab Vedotin, Pembrolizumab, and Quemliclustat for unresectable or metastatic urothelial cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.