Clinical Trial

Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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).
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2019-06-05; most recent amendment 2025-10-06.
Status change: Recruiting → Active, Not Recruiting 2023-12-07
Status change: Not Yet Recruiting → Recruiting 2019-06-17
Trial Details
NCT Number NCT03978624
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: Merck Sharp & Dohme LLC, Syndax Pharmaceuticals
Conditions Bladder Cancer
Enrollment 20 participants
Start Date 2020-09-23
Primary Completion 2024-03-25 (estimated)
Study Completion 2026-11-22 (estimated)
Updated on ClinicalTrials.gov 2025-10-15