A Phase II Study of Pembrolizumab and Interferon-gamma Immunotherapy for Persistent Mycosis Fungoides and Sezary Syndrome

Full Title

A Phase II Trial of MK-3475 (Pembrolizumab) and Interferon Gamma 1-b Combination Immunotherapy in Patients with Previously Treated Mycosis Fungoides and Sézary Syndrome

Purpose

Mycosis fungoides and Sezary syndrome (MF/SS) are diseases in which lymphocytes (a type of white blood cell) become cancerous and affect the skin, causing “cutaneous T-cell lymphoma.” In this study, researchers are assessing the safety and effectiveness of combining two types of immunotherapy to treat MF/SS that has continued to grow despite prior treatments, such as photodynamic therapy, chemotherapy, or radiation therapy. The immunotherapies are pembrolizumab and interferon-gamma.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. Pembrolizumab is already approved to treat several cancers and has helped some patients with lymphoma; its use in this study is considered investigational. It is given intravenously (by vein).

Interferon-gamma is a drug that also works by stimulating the immune system to help fight lymphoma. It is given by injection. The combination of pembrolizumab and interferon-gamma may be more effective than either drug alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MF/SS that has come back or continued to get worse despite at least one prior regimen of therapy.
  • A sufficient amount of time must pass after the completion of previous treatment to allow for “washout” of prior therapies from the body.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Moskowitz at 212-639-4839.

Protocol

17-540

Phase

II

Investigator

Co-Investigators