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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03978624
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg IV on day 1 and day 22
  • Entinostat — DRUG
    5 mg given orally on day 1, day 8 and day 15
  • Procedure/Surgery — PROCEDURE
    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.

Study Details

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).

Key Dates

Start date
Sep 23, 2020
Status verified
Oct 2025
Primary completion
Mar 25, 2024
Completion
Nov 22, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Pembrolizumab alone
    Subjects will be administered pembrolizumab alone 200 mg IV on day 1 and day 22
  • Experimental: B: Pembrolizumab plus Entinostat
    Subjects will be administered pembrolizumab on day 1 and day 22 and entinostat 5 mg given orally on day 1, day 8 and day 15

Primary Outcome Measure

Changes in CD8 T Cell Immune Gene Signature in the Pembrolizumab + Entinostat Group and the Pembrolizumab Group [ Time Frame: Pre-treatment and at time of definitive treatment within 10 weeks after starting neoadjuvant treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Related coverage on Hipa.ai

Find similar trials in Chapel Hill, NC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NCFox Chase Cancer Center· Philadelphia, PA

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