Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT03278782

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

Pembrolizumab

Romidepsin

Study Description

Brief 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.