A Phase 2 Study of Pembrolizumab Immunotherapy, Olaparib, and Temozolomide in People With Glioblastoma

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Full Title

A Surgical Window-of-Opportunity and Phase II Trial of Pembrolizumab, Olaparib and Temozolomide in Recurrent Glioblastoma

Purpose

Researchers are assessing a combination of three drugs for people with a brain tumor called glioblastoma. The three drugs are pembrolizumab, olaparib, and temozolomide.

The people in this study have glioblastoma that came back after treatment. In addition, they are planning to have surgery to remove some or all of the cancer.

Giving these drugs together may help them work better. Olaparib and temozolomide may stop or slow the growth of cancer cells. Pembrolizumab is an immunotherapy that boosts the power of the immune system to find and kill cancer cells. Olaparib and temozolomide are taken orally (by mouth) and pembrolizumab is given intravenously (by vein).

If you join this study, you will be randomly assigned to one of two groups:

  • One group will get pembrolizumab, olaparib, and temozolomide before and after glioblastoma surgery.
  • The other group will get pembrolizumab alone before surgery, followed by pembrolizumab, olaparib, and temozolomide after surgery.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have glioblastoma that came back after treatment and will be treated with surgery.
  • Have recovered from the serious side effects of prior treatment before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Lauren Schaff’s office at 212-610-0485.

Protocol

24-153

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05463848