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Study of Pembrolizumab (MK-3475) in Combination With Romidepsin | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

A Phase I/II Study of Pembrolizumab (MK-3475) in Combination With Romidepsin in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

NCT03278782•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.

Detailed Description

Primary Objectives: 1. Evaluate the safety of pembrolizumab in combination with romidepsin. 2. Estimate the response rate of the combination therapy in refractory or recurrent PTCL Secondary Objectives: 1. Estimate progression free survival (PFS). 2. Estimate overall survival (OS). 3. Estimate complete response (CR) and duration of response (DOR). 4. Estimate the event-free survival (EFS) and the failure free survival (FFS) 5. Estimate the overall response rate (ORR) per Lugano criteria. Exploratory Objectives: 1. Assess activation of T-cells after treatment in peripheral blood and tumor microenvironment. 2. Correlate features of peripheral blood T-cell activation with toxicities, clinical response, and PFS. OUTLINE: Participants receive romidepsin intravenously (IV) over 4 hours on days 1 and 8 or day 8 of cycle 1 and days 1 and 8 of subsequent cycles and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days and then every 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with peripheral T-cell lymphoma (including but not limited to PTCL-NOS, angioimmunoblastic T-cell lymphoma, anaplastic large T-cell lymphoma). Patients with mycosis fungoides with large cell transformation with measurable disease are eligible.
•2. Disease status defined as refractory to or relapsed after ≥ 1 prior treatment lines.
•3. Patients irrespective of transplant eligibility status can be enrolled; however patients can be seen by SCT team in anticipation for SCT.
•4. Subjects with ALK+ ALCL should have been treated with, be ineligible for, or have refused chemotherapy and brentuximab prior to enrollment on the current study.
•5. Patients with a measurable disease, defined by a node or mass with the longest diameter ≥ 1.5cm.
•In order to be eligible for participation in this trial, the subject must:
•1. Be willing and able to provide written informed consent/assent for the trial.
•2. Be 18 years of age on day of signing informed consent.
•3. Patients with PTCL should have radiographically measurable disease \>/= 1.5cm.
•4. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 12 weeks(84 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
+22 more criteria

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject:
•1. Is currently receiving study therapy 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 treatment.
•2. Has a diagnosis of immunodeficiency, is receiving systemic steroids above physiologic dose (\>10mg/day prednisone or equivalent) within 5 half lives after the last dose of steroid of start of therapy or is receiving any other form of immunosuppressive therapy.
•3. Has a known history of active TB (Bacillus Tuberculosis)
•4. Hypersensitivity to pembrolizumab or any of its excipients.
•5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•7. Has a known additional malignancy that is progressing or requires active treatment within the last 3 years Exceptions include basal cell carcinoma of the skin, resected renal cell cancer or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
+14 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

November 14, 2017

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2027

Last Updated

January 9, 2026

Enrollment

ACTUAL participants

Conditions

Recurrent Anaplastic Large Cell LymphomaRecurrent Angioimmunoblastic T-Cell LymphomaRecurrent Mature T- and NK-Cell Non-Hodgkin LymphomaRecurrent Mycosis FungoidesRecurrent Primary Cutaneous T-Cell Non-Hodgkin LymphomaRefractory Anaplastic Large Cell LymphomaRefractory Angioimmunoblastic T-Cell LymphomaRefractory Mature T-Cell and NK-Cell Non-Hodgkin LymphomaRefractory Mycosis FungoidesRefractory Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedRefractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Interventions

Pembrolizumab

BIOLOGICAL

Romidepsin

DRUG

Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

NCT03011814

Folliculotropic Mycosis FungoidesRecurrent Cutaneous T-Cell Non-Hodgkin Lymphoma+6 more

View study

COMPLETEDPHASE1

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas

NCT01897012

MYC PositiveRecurrent B-Cell Non-Hodgkin Lymphoma+15 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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