A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer (NEPTUNE)
University of Michigan Rogel Cancer Center
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.
Description
08JUL2026- Amendment processed updating study title and primary outcome measure to remove the cisplatin eligible requirement as well as updates to the inclusion/exclusion criteria.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a diagnosis of high-grade upper tract (renal pelvis and/or ureter) urothelial carcinoma proven by biopsy or cytology within 60 days prior to registration with the following (cT1-4 N0-1 M0): a. Upper urinary tract mass on cross-sectional imaging or Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology. b. No regional lymph node metastasis, a single regional lymph node metastasis, or multiple regional lymph node metastases (no distant lymph node metastases) * Patients must not have any component of small cell…
Interventions
- DrugEnfortumab vedotin
1.25 mg/kg IV
- DrugPembrolizumab
200 mg IV
Locations (2)
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania