Trials / Recruiting
RecruitingNCT06356155
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enfortumab vedotin | 1.25 mg/kg IV |
| DRUG | Pembrolizumab | 200 mg IV |
Timeline
- Start date
- 2025-07-22
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
- First posted
- 2024-04-10
- Last updated
- 2025-07-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06356155. Inclusion in this directory is not an endorsement.