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NCT05656235 · ClinicalTrials.gov registry record · Phase 2
Renal Retention in High Grade Upper Tract Urothelial Cancer
A Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT05656235: Recruiting Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT05656235 is a Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05656235, a Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.
Primary Outcome
Time to relapse or death based on 12 months.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab vedotin
Study Locations (2)
District of Columbia
- Johns Hopkins University: Sibley Memorial Hospital - Washington D.C.
Maryland
- Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
What NCT05656235 shows while recruiting
NCT05656235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05656235 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05656235 about?
NCT05656235 is a clinical study titled "Renal Retention in High Grade Upper Tract Urothelial Cancer". This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) ...
What is the current status of trial NCT05656235?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-11-25. Estimated completion is 2029-06.
What conditions does trial NCT05656235 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma Bladder, High Grade Urothelial Carcinoma.
What interventions are being tested in trial NCT05656235?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT05656235?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05656235 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05656235's enrollment target sits among peer trials
20 149th of 175 higher than 22 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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.
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