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LymphomaPhase 2NCT03179930

Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas

A Phase 2 study testing Entinostat and Pembrolizumab in people with Lymphoma and Relapsed, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to test any good and bad effects of the study drugs called Pembrolizumab and Entinostat when used in combination to treat lymphoma. This combination could shrink the lymphoma but it could also cause side effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Relapsed, Refractory
What is being tested?
Entinostat and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
9 sitesUnited States
Study dates
7 Jun 2017to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥ 18 years of age at the time of signing Informed Consent
  • Patient has histologically confirmed diagnosis of classical Hodgkin lymphoma at enrolling institution.
  • Hodgkin lymphoma patients must have received at least 2 prior regimens. Patients should have declined, or be ineligible for autologous transplant
  • Prior HDAC inhibitor and/or anti-PD1, anti-PDL1, anti-PD-L2, anti-CD137 or anti-cytotoxic T- lymphocyte associated antigen 4 (CTLA-4) antibody allowed as long patient received clinical benefit from it. Patients can currently be on a checkpoint inhibitor or HDAC inhibitor, including one of the study drugs, at time of screening.
  • Patient has at least one site of measurable disease (≥ 1.5 cm), which may be lymph node or extranodal lesion, which is seen on screening imaging studies within 28 days of start of study drug
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
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  • Patient has adequate bone marrow and organ function by:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
  • Platelets ≥75 x 10^9/L
  • Hemoglobin (Hgb) ≥ 9.0 g/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x ULN (or
  • ≤3 x ULN if liver involved with disease
  • Total serum bilirubin or plasma bilirubin ≤ 1.5 x ULN ( ≤ 3 x ULN with direct bilirubin within normal range in patients with documented hepatic involvement, well documented Gilbert"s Syndrome)
  • International Normalized Ratio (INR) or Prothrombin
  • Time (PT) ≤1.5×ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Patients with GFR>45 ml/min. Patients with GFR 45-59 ml/min are eligible but will undergo dose adjustments as specified in section 9.0.1
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception. Subjects must adhere to the contraception requirement from the day of study medication initiation, (or 14 days prior to the initiation of study medication for oral contraception) throughout the entire study, and up 120 days after the last dose of trial therapy.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Male subjects of childbearing potential (Section 9.8.2) must agree to use an adequate method of contraception as outlined in Section 9.8.2- Subjects must adhere to the contraception requirement from the day of study medication initiation, (or 14 days prior to the initiation of study medication for oral contraception) throughout the entire study, and up 120 days after the last dose of trial therapy.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Who cannot join

  • Diagnosed or treated for malignancy other than the indication under study except for
  • Malignancy treated with curative intent and with no known active disease present for at least 2 years before the first dose of study treatment
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • History of Human Immunodeficiency Virus (HIV)
  • Active Hepatitis B or C infection
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  • History of active TB (Bacillus Tuberculosis)
  • Concurrent enrollment in another therapeutic investigational clinical study or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug
  • Known CNS lymphoma involvement
  • Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator"s opinion, could compromise the subject"s safety, interfere with the absorption or metabolism of entinostat capsules, or put the study outcomes at undue risk.
  • Any history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non- infectious pneumonitis
  • Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 470 msec.
  • History of Torsades de pointes, ventricular tachycardia, or ventricular fibrillation within 6 months prior to screening
  • Uncontrolled heart failure or hypertension or uncontrolled diabetes mellitus
  • Any active autoimmune disease or a documented history of autoimmune disease (excluded/exception to the rule: subjects with vitiligo or resolved childhood asthma/atopy, type I diabetes mellitus, subjects with hypothyroidisms stable on hormone replacement, Sjorgen"s syndrome, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger).
  • Any syndrome that requires ongoing systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration. Of note: Inhaled or topical steroids, and adrenal replacement doses are permitted
  • Women who are pregnant or breast feeding
  • Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or has persistent and uncontrolled adverse events from most recent prior therapy.
  • Patient has had prior allogenic tissue/solid organ transplant <1 year ago
  • °Participants with prior allo transplant >1 year ago may enroll if:
  • Patient does not have active GVHD and has discontinued all GVHD-related medications.
  • Has received at least 3 doses of PD-1 blockade after allogeneic stem cell transplant without developing acute or chronic GVHD
  • Patient may enroll after discussion with MSK PI
  • Has had recent chemotherapy within 2 weeks prior to study day 1
  • Has had recent small molecule therapy within 3 half-lives of agent prior to study day 1
  • °Participants must have recovered from all AEs due to previous therapies to </= Grade 1 or baseline. Participants with </= Grade 2 neuropathy may be eligible
  • Has received radiotherapy (with the exclusion of radiation to one area [e.g. involved nodal sit] that does not interfere with response assessment in other sites) within 2 weeks prior to study day 1
  • °Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  • Allergy to benzamide or inactive components of entinostat

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Roswell Park Cancer Institute (Data Collection Only)

    Buffalo, New York, 14263-0001

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Northwestern University (Data Collection Only)

    Evanston, Illinois, 60208

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase II Study of Pembrolizumab and Entinostat in Patients With Relapsed and Refractory Lymphomas

The purpose of this study is to test any good and bad effects of the study drugs called Pembrolizumab and Entinostat when used in combination to treat lymphoma. This combination could shrink the lymphoma but it could also cause side effects. Researchers also hope to learn whether adding entinostat to pembrolizumab can be more effective for patients with lymphoma than either drug alone.

Being tested
Entinostat, Pembrolizumab
Keywords
Entinostat, Pembrolizumab, 17-073
Medical subject headings
Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntinostatDrug

    All patients will receive entinostat 5-7 mg PO as per the dosing regimen at the on D1, D8, and D15

  • PembrolizumabDrug

    pembrolizumab 200 mg IV on D1

Study groups in NCT03179930
Study groupRoleWhat they receive
Entinostat and PembrolizumabExperimentalpatients will be assigned to receive therapy with entinostat given by mouth once weekly and pembrolizumab given intravenously every 3 weeks
Receives: Drug: Entinostat; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival rate

    Determine the 12 month progression-free survival rate of entinostat when administered in combination with pembrolizumab in patients with relapsed and refractory Hodgkin and follicular lymphomas.

    Measured: 12 months

Secondary outcomes (1)

  1. Overall response rate

    Determine overall response rate of participants on entinostat and pembrolizumab

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start7 Jun 2017
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a protocol comprised of a multicenter phase II study in FL and HL
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179930
Sponsor's protocol ID
17-073
Status last verified
Oct 2026
First submitted
6 Jun 2017
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Entinostat and Pembrolizumab in people with Lymphoma and Relapsed, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03179930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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