A Phase II Study of Pembrolizumab Immunotherapy plus Gemcitabine to Treat Advanced Mycosis Fungoides or Sézary Syndrome

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Full Title

Pembrolizumab in Combination with Gemcitabine for Previously Treated Mycosis Fungoides and Sézary Syndrome: Efficacy and Characterization of Immune Response

Purpose

Mycosis fungoides and Sézary syndrome are two types of lymphoma. They are both diseases in which lymphocytes (a type of white blood cell) become cancerous and affect the skin. In this study, researchers are assessing the safety and effectiveness of combining the immunotherapy drug pembrolizumab with the chemotherapy drug gemcitabine in people with mycosis fungoides or Sézary syndrome that has gotten worse despite treatment.

Pembrolizumab works by enhancing the ability of the immune system to find and kill cancer cells. Gemcitabine is already used to treat advanced mycosis fungoides and Sézary syndrome. Laboratory studies have shown that gemcitabine is more effective when given with an immunotherapy drug like pembrolizumab. Both medications are given intravenously (by vein).

Eligibility

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

  • Participants must have mycosis fungoides or Sézary syndrome that has gotten worse despite treatment.
  • At least 2 weeks must pass between the completion of prior therapies and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please call the office of Dr. Alison Moskowitz at 646-608-3726.

Protocol

21-242

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators