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Monoclonal Antibodies

Pembrolizumab + Entinostat for Bladder Cancer

Phase 2
Waitlist Available
Led By Tracy L Rose, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of the study treatment
Histological confirmation of urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible. Pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining immunotherapy with a class I HDAC inhibitor. The goal is to see if the treatment changes immunogenomic markers in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based neoadjuvant chemotherapy.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related reactions, fatigue, skin issues, digestive problems, liver inflammation, hormone gland changes. Entinostat could lead to blood cell count changes, fatigue, nausea, diarrhea, changes in sense of taste.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and have a recent negative pregnancy test.
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My bladder cancer diagnosis includes urothelial carcinoma.
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My bladder cancer is at a stage where it has grown but not spread to distant parts.
Select...
I can take and keep down pills.
Select...
I am 18 years old or older.
Select...
I am scheduled for a surgery to remove my bladder.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I cannot or choose not to receive cisplatin-based chemotherapy due to my health condition.
Select...
I have a preserved tumor sample that can provide 15 to 20 slides for testing.
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I agree to donate tissue from my bladder surgery and blood before and at the time of my surgery.
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I am a man who can father children and agree to use birth control as required, starting with the first dose of study therapy through 120 days after the last dose.
Select...
My organ functions are within normal ranges as required.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Z-score of T cell CD8 immune 37-gene signature
Secondary outcome measures
Histones
Change from baseline in number and character of neoantigens
Event Free Survival (EFS)
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: B: Pembrolizumab plus EntinostatExperimental Treatment2 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 Treatment1 Intervention
Subjects will be administered pembrolizumab alone 200 mg IV on day 1 and day 22
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entinostat
2017
Completed Phase 2
~1170
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,224 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,712 Total Patients Enrolled
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,781 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03978624 — Phase 2
Bladder Cancer Research Study Groups: A: Pembrolizumab alone, B: Pembrolizumab plus Entinostat
Bladder Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03978624 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03978624 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you inform me of the additional experiments related to Pembrolizumab?

"Pembrolizumab was first studied at Johns Hopkins University/Sidney Kimmel Cancer Center in 2009 and there are now 281 concluded studies. Currently, 974 live clinical trials of this medication exist; many of which take place in Philadelphia, Pennsylvania."

Answered by AI

Is the research team currently recruiting participants?

"Affirmative. According to the information located on clinicaltrials.gov, this study is currently recruiting participants with an initial posting date of September 23rd 2020 and most recent update from October 10th 2022. It requires 20 subjects at two sites for enrolment."

Answered by AI

What is the current cap on enrollees for this clinical trial?

"Affirmative. Clinicaltrials.gov details that this medical trial, initially posted on September 23rd 2020, is actively searching for participants. Up to twenty patients are sought from two clinical sites."

Answered by AI

Has the Federal Drug Administration sanctioned Pembrolizumab?

"After careful assessment, the safety of Pembrolizumab was rated a 2 on the 1-3 scale. This is because only preliminary evidence exists to support its efficacy and there is some data suggesting it can be safely administered in medical trials."

Answered by AI

To what conditions is Pembrolizumab usually prescribed?

"Pembrolizumab is primarily employed to fight cancerous tumors, but it may also be used for issues like unresectable melanoma, microsatellite instability high, and chemotherapy-resistant disease progression."

Answered by AI

Do I qualify to partake in this research project?

"This clinical trial is currently recruiting 20 participants with bladder cancer between the ages of 18 and 99. To be eligible, individuals must meet the following requirements: Being at least eighteen years old when signing consent forms; Having an Eastern Cooperative Oncology Group performance status that does not exceed 2.; Being diagnosed with urothelial carcinoma of the bladder (mixed histologies are also applicable); Not having pure small cell carcinoma, adenocarcinoma or squamous cell carcinoma; Planning to have definitive surgery done (radical cystectomy)."

Answered by AI

Does this medical investigation accept participants aged fifty or over?

"This medical experiment requires that potential participants are aged between 18 and 99. It should also be noted that there is a separate 38 studies devoted to testing on those under the age of majority, as well as 1339 different trials for elderly individuals over 65 years old."

Answered by AI
~4 spots leftby Mar 2025