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Histone Deacetylase Inhibitor

Pembrolizumab + Entinostat for Lymphoma

Phase 2
Waitlist Available
Led By Gottfried von Keudell, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hodgkin lymphoma patients must have received at least 2 prior regimens and should have declined or be ineligible for autologous transplant
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effects of two drugs, Pembrolizumab and Entinostat, when used together to treat lymphoma. The goal is to see if the combination is more effective than either drug used alone, and to learn about any potential side effects.

Who is the study for?
Adults over 18 with classical Hodgkin lymphoma, who have tried at least two treatments and aren't eligible for a transplant. They must have measurable disease, be in good physical condition (ECOG ≤ 1), and have proper organ function. Women of childbearing age need a negative pregnancy test and agree to use contraception; men also must commit to using birth control.
What is being tested?
The trial is testing the combination of Pembrolizumab and Entinostat against lymphoma to see if they're more effective together than alone. The goal is to shrink the cancer but researchers are also watching for any side effects that might occur from this drug combo.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs, infusion-related reactions, tiredness, stomach issues like nausea or diarrhea, blood cell count changes which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Hodgkin lymphoma and have tried at least 2 treatments but can't or won't get a stem cell transplant.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My diagnosis of classical Hodgkin lymphoma is confirmed by tissue analysis.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Response using the 2014 Lugano Classification

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%
Systemic infection
1%
Clostridium difficile colitis
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
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Entinostat and PembrolizumabExperimental Treatment2 Interventions
patients will be assigned to receive therapy with entinostat given by mouth once weekly and pembrolizumab given intravenously every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Entinostat
2017
Completed Phase 2
~1320

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,973 Previous Clinical Trials
597,691 Total Patients Enrolled
156 Trials studying Lymphoma
9,035 Patients Enrolled for Lymphoma
Merck Sharp & Dohme LLCIndustry Sponsor
4,019 Previous Clinical Trials
5,186,460 Total Patients Enrolled
97 Trials studying Lymphoma
8,961 Patients Enrolled for Lymphoma
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,763 Total Patients Enrolled
1 Trials studying Lymphoma
49 Patients Enrolled for Lymphoma

Media Library

Entinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03179930 — Phase 2
~2 spots leftby Jun 2025
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