NCT03278782

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Romidepsin	Given IV

Timeline

• Start date: 2017-11-14
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2017-09-12
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study