A Phase II Study of Pembrolizumab Immunotherapy, Olaparib, and Temozolomide in People with Recurrent Glioma

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Full Title

A Phase II Study of Pembrolizumab, Olaparib, and Temozolomide in Patients with Glioma

Purpose

The purpose of this study is to assess the safety and effectiveness of combining three drugs to treat people with an IDH-mutant glioma that came back after chemotherapy or surgery. The three medications are pembrolizumab, olaparib, and temozolomide. 

Pembrolizumab takes the brakes off the immune response, helping immune cells to find and destroy cancer cells. Olaparib blocks a protein called PARP that repairs damage to a cell’s DNA before the cell divides and can make cancers more vulnerable to treatment. Temozolomide is the current standard of care for most gliomas; the drug prevents DNA repair in cancer cells. Pembrolizumab is given intravenously (by vein) and olaparib and temozolomide are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including

  • Participants must have IDH-mutated glioma that returned after prior chemotherapy or surgery.
  • The serious side effects of previous therapies should get better before the patient receives 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 and to ask about eligibility for this study, please contact the office of Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 866-886-9807.

Protocol

20-091

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators