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

NCT03978624 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-15

Study results available
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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

Interventions

DRUG

Pembrolizumab

200 mg IV on day 1 and day 22

DRUG

Entinostat

5 mg given orally on day 1, day 8 and day 15

PROCEDURE

Procedure/Surgery

A radical cystectomy is a surgical procedure to remove the entire urinary bladder and maximal transurethral resection of bladder tumor (TURBT) is a surgical procedure used to remove as much of the bladder tumor as possible.

Sponsors & Collaborators

Principal Investigators

  • Tracy L Rose, MD · UNC- Chapel HIll

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2024-03-25
Completion
2026-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978624 on ClinicalTrials.gov