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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
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
Subject has clinical stage T2-T4a N0/X M0 urothelial carcinoma. Clinical T stage is based on the pre-study standard of care transurethral resection of the bladder tumor (TURBT) sample and imaging studies (abdominal/pelvic CT or MRI scan and CT scan of the chest performed within 4 weeks prior to treatment initiation)
Must not have
Subject has a known history of active tuberculosis
Subject has known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] has been detected)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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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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.
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I can take and keep down pills.
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I am 18 years old or older.
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I am scheduled for a surgery to remove my bladder.
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I can take care of myself and am up and about more than half of my waking hours.
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I cannot or choose not to receive cisplatin-based chemotherapy due to my health condition.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active tuberculosis infection.
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I have a history of Hepatitis B or C.
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I am allergic to pembrolizumab or its components, and if in arm 2, also to benzamide or entinostat's inactive ingredients.
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I have previously been treated with specific immune system targeting drugs.
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I am taking medication that affects P-gp for my treatment.
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I have had radiation therapy on my bladder for cancer treatment.
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I have an immune system disorder or have been on immune-weakening medication recently.
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I have not received a live vaccine in the last 30 days.
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I have a gut condition that affects how my body absorbs medication.
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I am currently taking medications that affect cell DNA, like valproic acid.
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I have been diagnosed with HIV.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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I have had pneumonitis treated with steroids or have it now.
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I am currently being treated for an infection.

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

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

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1320
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
363 Previous Clinical Trials
91,988 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,223 Total Patients Enrolled
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,790 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
~4 spots leftby Nov 2025
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