Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas

NCT03179930 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 17-073
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 9

Brief 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. Researchers also hope to learn whether adding entinostat to pembrolizumab can be more effective for patients with lymphoma than either drug alone.

Conditions

Lymphoma; Relapsed; Refractory

Keywords

Entinostat; Pembrolizumab; 17-073

Outcome Measures

Primary Outcomes (1)

• Response using the 2014 Lugano Classification

  will be evaluated in this study using the 2014 Lugano Classification.

  2 years

Study Arms (1)

Entinostat and Pembrolizumab

EXPERIMENTAL

patients will be assigned to receive therapy with entinostat given by mouth once weekly and pembrolizumab given intravenously every 3 weeks

Drug: Entinostat; Drug: Pembrolizumab

Interventions

Entinostat DRUG

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

Entinostat and Pembrolizumab

Pembrolizumab DRUG

pembrolizumab 200 mg IV on D1

Entinostat and Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator
• Syndax Pharmaceuticals: collaborator

Study Sites (9)

Northwestern University (Data Collection Only)

Evanston, Illinois, 60208, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Roswell Park Cancer Institute (Data Collection Only)

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma; Recurrence

Interventions

entinostat; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Moskowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a protocol comprised of a multicenter phase II study in FL and HL

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: June 7, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (9)