NCT05868265

A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract

Neoadjuvant Enfortumab Vedotin in High-Grade Urothelial Carcinoma of the Upper Urinary Tract (Including Ureter and Renal Pelvis)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Enfortumab Vedotin	All patients will receive enfortumab vedotin at 1.25 mg/kg on days 1 and 8 of 21 days cycle, for a total of three cycles.
PROCEDURE	Radical surgery	Radical surgery, such as radical nephroureterectomy, nephrectomy or ureterectomy is to take place within 60 days from the last dose of treatment end of cycle 3 (i.e., cycle 3 day 22).

Timeline

• Start date: 2023-06-02
• Primary completion: 2027-06-02
• Completion: 2027-06-02
• First posted: 2023-05-22
• Last updated: 2026-02-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study