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NCT06356155 · ClinicalTrials.gov registry record · Phase 2
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer
A Phase 2 study of Urothelial Carcinoma, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06356155: Recruiting Phase 2 study of Urothelial Carcinoma, sponsored by University of Michigan Rogel Cancer Center.
NCT06356155 is a Phase 2 study of Urothelial Carcinoma that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 32 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06356155, a Phase 2 study of Urothelial Carcinoma, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This trial will estimate the efficacy of combination enfortumab vedotin and pembrolizumab given as neoadjuvant therapy in patients with localized/locally advanced upper tract urothelial cancer (cT2-4 N0-1 M0) followed by definitive surgery. The historic pT0/Ta/Tis/T1 (termed 'response' herein) rate with definitive surgery alone for a comparable patient population (H0) is approximately 20%. This study targets an improvement of 20% in the response proportion to a target 40% response rate (H1) with
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab vedotin
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What NCT06356155 shows while recruiting
NCT06356155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06356155 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06356155 about?
NCT06356155 is a clinical study titled "Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer". 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 ...
What is the current status of trial NCT06356155?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2025-07-22. Estimated completion is 2028-03.
What conditions does trial NCT06356155 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT06356155?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT06356155?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06356155 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urothelial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06356155's enrollment target sits among peer trials
32 62nd of 85 higher than 23 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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