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NCT03978624 · ClinicalTrials.gov registry record · Phase 2
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
A Phase 2 study of Bladder Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03978624 is a Phase 2 study of Bladder Cancer that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. 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.
The verdict
NCT03978624, a Phase 2 study of Bladder Cancer, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label, window of opportunity platform study for subjects with muscle-invasive bladder cancer (MIBC) who are deemed ineligible or refuse cisplatin-based neoadjuvant chemotherapy and are scheduled to undergo definitive surgery (radical cystectomy), or are planning to undergo trimodality therapy (maximal transurethral resection of the bladder tumor followed by concurrent chemoradiation). The primary objective of this study is to assess changes to immunogenomic markers after treatment with pembrolizumab alone and in combination with the selective class I histone deacetylase (HDAC) inhibitor (entinostat).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Entinostat
- PROCEDURE Procedure/Surgery
Study Locations (2)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2026-11-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03978624
The ClinicalTrials.gov registry entry for NCT03978624 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03978624 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03978624 about?
NCT03978624 is a clinical study titled "Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer". This is an open-label, window of opportunity platform study for subjects with muscle-invasive bladder cancer (MIBC) who are deemed ineligible or refuse cisplatin-based neoadjuvant chemotherapy and are scheduled to undergo definitive surgery (radical cystectomy), or are planning to undergo trimodalit...
What is the current status of trial NCT03978624?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-09-23. Estimated completion is 2026-11-22.
What conditions does trial NCT03978624 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT03978624?
The interventions under investigation include: Pembrolizumab (DRUG), Entinostat (DRUG), Procedure/Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03978624?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03978624 being conducted?
This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.