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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

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response using the 2014 Lugano Classification

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%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~2010
Entinostat
2017
Completed Phase 2
~1210

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,704 Total Patients Enrolled
155 Trials studying Lymphoma
8,712 Patients Enrolled for Lymphoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,216 Total Patients Enrolled
92 Trials studying Lymphoma
8,615 Patients Enrolled for Lymphoma
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,769 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
~5 spots leftby Jun 2025
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