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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03278782
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 14, 2017
Completion date July 31, 2024

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