A Pilot Study of Pembrolizumab Immunotherapy in Patients with Extranodal NK/T-cell Nasal-Type Lymphoma

Full Title

PAC Protocol MCT: Pilot Study of Pembrolizumab in Untreated Extranodal, NK/T cell Lymphoma, Nasal Type

Purpose

Researchers have found that pembrolizumab immunotherapy can shrink extranodal natural killer T-cell lymphoma (ENKTL) when the disease comes back after chemotherapy. The purpose of this study is to see how well pembrolizumab shrinks nasal-type ENKTL in people who have not yet received chemotherapy.

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. It is used to treat several types of cancer and is given intravenously (by vein); its use in this study is considered investigational.

There are two treatment groups in this study:

  • Patients with early-stage (stage I-II) ENKTL will receive four doses of pembrolizumab. Those who have complete tumor shrinkage will have radiation therapy followed by eight more doses of pembrolizumab. Those who don’t respond well to pembrolizumab will have standard chemotherapy and radiation therapy for ENKTL.
  • Patients with late-stage (stage III-IV) ENKTL will receive four doses of pembrolizumab. Those who have complete tumor shrinkage will have standard ENKTL chemotherapy followed by eight more doses of pembrolizumab. Those who don’t respond well to pembrolizumab will have standard treatment for late-stage ENKTL, which may include chemotherapy plus a stem cell transplant.

Eligibility

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

  • Patients must have previously untreated nasal-type ENKTL.
  • 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 and to inquire about eligibility for this study, please contact Dr. Alison Moskowitz at 212-639-4839.

Protocol

18-393

Phase

Pilot

Disease Status

Newly Diagnosed

Investigator