Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Bladder Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Gene expression levels with the CD8 T cell gene signature were measured using RNA sequencing. The expression level of each gene in the signature were log2 transformed and the mean of the signature genes was calculated in each sample. Then the mean expression of signature in each sample was compared to the average expression and variability across other sample to center the expression values (mean = 0) and scale them by standard deviation and generate a Z-score. Change in z-score was then calcula
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 |
What the registry record for NCT03978624 still lists
NCT03978624 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 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03978624 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
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 NCT03978624'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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Telehealth Intervention for Ostomy Self-Management
RECRUITING · Phase 2
-
Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
RECRUITING · Phase 2
-
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
RECRUITING · Phase 2
-
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
RECRUITING · Phase 2
-
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
RECRUITING · Phase 2
-
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI