RecruitingPhase 2NCT06356155

Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer

A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer (NEPTUNE)


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

32 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Enfortumab vedotin and a drug called Pembrolizumab for people with urothelial carcinoma. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

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

1.25 mg/kg IV

DRUGPembrolizumab

200 mg IV


Locations(2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06356155


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