Pembrolizumab + Romidepsin for Lymphoma

Overseen by Swaminathan P. Iyer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Swaminathan P. Iyer

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for people with peripheral T-cell lymphoma that's come back or didn't respond to treatment. They must have had at least one prior treatment, be in good physical condition (ECOG 0 or 1), and have adequate organ function. Pregnant women can't participate, and participants must agree to use contraception.

Inclusion Criteria

Patients irrespective of transplant eligibility status can be enrolled; however, patients can be seen by SCT team in anticipation for SCT

I am at least 18 years old.

My PTCL is visible on scans and is larger than 1.5cm.

Exclusion Criteria

I am currently on medication for an infection.

I have not received a live vaccine in the last 30 days.

I have had or currently have lung inflammation treated with steroids.

Treatment Details

Interventions

• Pembrolizumab (Monoclonal Antibodies)
• Romidepsin (Histone Deacetylase Inhibitor)

Trial Overview The study tests pembrolizumab combined with romidepsin against recurrent or refractory peripheral T-cell lymphoma. Pembrolizumab boosts the immune system to fight cancer, while romidepsin blocks enzymes needed for tumor cell growth.

Participant Groups

Group I: Treatment (romidepsin, pembrolizumab) Experimental Treatment 2 Interventions

Participants receive romidepsin 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School