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Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer - Trial NCT06356155

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.

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NCT06356155
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06356155
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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)

Study Focus

Urothelial Carcinoma

Enfortumab vedotin

Interventional

drug

Sponsor & Location

University of Michigan Rogel Cancer Center

Ann Arbor, United States of America

Timeline & Enrollment

Phase 2

Oct 01, 2024

Jul 01, 2027

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 organs
Malignant neoplasm of ureter
Malignant neoplasms of urinary tract
Malignant neoplasm: Overlapping lesion of urinary organs
Malignant neoplasm: Urethra

Data Source

ClinicalTrials.gov

NCT06356155

Non-Device Trial