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

NCT03278782 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Angioimmunoblastic T-Cell Lymphoma
  • Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Mycosis Fungoides
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Romidepsin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Swaminathan P Iyer, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278782 on ClinicalTrials.gov