RecruitingPhase 2NCT05868265

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)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

24 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called enfortumab vedotin in people with a specific type of kidney and urinary tract cancer called upper tract urothelial carcinoma. The goal is to shrink the tumour before surgery, so that the kidney can potentially be spared. **You may be eligible if...** - You have been diagnosed with high-grade urothelial cancer of the upper urinary tract (kidney or ureter) - Your cancer appears to be at a stage where it has not spread to distant organs - You are being considered for surgery **You may NOT be eligible if...** - Your cancer has already spread to distant parts of the body - You have certain serious health conditions that make the study drug unsafe - You cannot complete the required scans and procedures Talk to your doctor to see if this trial is right for you.

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

DRUGEnfortumab 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.

PROCEDURERadical 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).