A Phase I/II Study of Tabelecleucel plus Pembrolizumab Immunotherapy in Patients with Recurrent or Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Cancer

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Full Title

An Open-Label Phase 1B/2 Study to Evaluate the Safety and Efficacy of Tabelecleucel in Combination with Pembrolizumab in Subjects with Platinum-pretreated, Recurrent/Metastatic Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma

Purpose

The purpose of this study is to find the highest dose of the drug tabelecleucel that can be given safely with pembrolizumab immunotherapy in patients with nasopharyngeal cancer caused by the Epstein-Barr virus (EBV). Researchers think that tabelecleucel will make the immune system respond better to treatment with pembrolizumab.

Tabelecleucel is a cellular therapy made of white blood cells called cytotoxic T lymphocytes (CTLs) which have been expanded in the laboratory, starting with cells from a healthy person who is immune to EBV. The cells recognize and destroy EBV-infected cells in the recipient. Patients receive EBV-CTLs from a partially matched donor. Clinical trials at Memorial Sloan Kettering have found that tabelecleucel may be an effective treatment for patients with EBV-associated cancers.

Pembrolizumab works by boosting the power of the immune system to find and kill cancer cells by blocking PD-1. It is used to treat many types of cancer; its use in this study with tabelecleucel is considered investigational. Both tabelecleucel and pembrolizumab are given intravenously (by vein).

Eligibility

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

  • Patients must have EBV-related nasopharyngeal cancer that came back or spread despite prior treatment that included a platinum-containing drug.
  • Patients should recover from the serious side effects of prior treatment before entering the study.
  • Prior treatment with pembrolizumab or similar immunotherapies is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Pfister at 646-888-4237.

Protocol

19-194

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators