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NCT06356155

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

A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE)
University of Michigan Rogel Cancer Center·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Urothelial Carcinoma
Drug/Device/Intervention
Enfortumab vedotin
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Michigan Rogel Cancer Center
Location
Ann Arbor, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Oct 01, 2024
End date
Jul 01, 2027
Enrollment
32 participants
Primary outcome

Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in cisplatin-eligible patients based off pathological response

Summary

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of
 enfortumab vedotin and pembrolizumab in cisplatin-eligible 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.

ICD-10 classifications
Carcinoma in situ: Other and unspecified urinary organsMalignant neoplasm of ureterMalignant neoplasms of urinary tractMalignant neoplasm: Overlapping lesion of urinary organsMalignant neoplasm: Urethra
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06356155
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06356155 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of Michigan Rogel Cancer Center and is currently Not yet recruiting. The study focuses on Urothelial Carcinoma. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.