drugset / Trial / NCT06356155

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

NCT06356155

Phase 2 Recruiting 32 enrolled University of Michigan Rogel Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-22
Primary completion
2028-03
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Enfortumab Vedotin Other / unclassified 1.25 mg/kg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications