Clinical Trial

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

Study acronym: NEPTUNE
Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-17
Trial Details
NCT Number NCT06356155
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions Urothelial Carcinoma
Enrollment 32 participants
Start Date 2025-07-22
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-16