Pembrolizumab + Entinostat for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byTracy L Rose, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

Tracy L Rose, MD

Principal Investigator

UNC- Chapel HIll

Eligibility Criteria

Adults with muscle-invasive bladder cancer who can't or won't take cisplatin-based chemo and are set for surgery or trimodality therapy. They must be able to provide tissue samples, have a life expectancy over 3 months, and show adequate organ function. Women of childbearing age need to use contraception.

Inclusion Criteria

I am a woman who can have children and have a recent negative pregnancy test.

My bladder cancer diagnosis includes urothelial carcinoma.

My bladder cancer is at a stage where it has grown but not spread to distant parts.

See 12 more

Exclusion Criteria

I am taking medication that affects P-gp for my treatment.

Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have an active tuberculosis infection.

See 18 more

Treatment Details

Interventions

Entinostat (Histone Deacetylase Inhibitor)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study is testing the effects of Pembrolizumab alone and combined with Entinostat on immune markers in bladder cancer patients ineligible for certain chemotherapy before their scheduled surgeries.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: B: Pembrolizumab plus EntinostatExperimental Treatment3 Interventions

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

Group II: A: Pembrolizumab aloneExperimental Treatment2 Interventions

Subjects will be administered pembrolizumab alone 200 mg IV on day 1 and day 22