A Phase II Study of a Genetically Modified Virus plus Pembrolizumab Immunotherapy to Treat Recurrent Glioblastoma and Gliosarcoma Brain Tumors

Full Title

A Phase II, Multi-Center, Open-Label Study of a Conditionally Replicative Adenovirus (DNX-2401) with Pembrolizumab (Keytruda®) for Recurrent Glioblastoma or Gliosarcoma

Purpose

In this study, researchers are evaluating the combination of a genetically modified virus plus pembrolizumab immunotherapy to treat glioblastoma and gliosarcoma brain tumors that have continued to grow despite prior treatment. The virus, DNX-2401, is a form of the common cold virus and is altered so that it can selectively enter and kill brain tumor cells. It will be injected into patients’ tumors during a surgical procedure. Researchers in this study are determining the best dose of DNX-2401 to give.

Patients will also receive pembrolizumab for two years after the virus injection. Pembrolizumab boosts the immune system’s ability to find and destroy cancer cells. It works by blocking a molecule called PD-1 that shuts down the immune response. Pembrolizumab is already approved to treat several cancers; its use in this study is considered investigational. It is 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 glioblastoma or gliosarcoma that continues to grow despite previous treatment with temozolomide and radiation therapy.
  • At least 3 weeks must pass since the last dose of temozolomide and 12 weeks since the last radiation treatment and entry into the study.
  • Patients must have a tumor that can be accessible to injection of the virus.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mariza Daras at 212-610-0239.

Protocol

17-228

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators