Study on Surgery with Pembrolizumab, Olaparib, and Temozolomide for Recurrent Glioblastoma

Sponsor: L. Nicolas Gonzalez Castro, MD, PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05463848

Provider View

This clinical trial is exploring a combination of treatments, including surgery, to see if they can help manage recurrent glioblastoma, a type of brain tumor that has returned or continued to grow after previous treatments.

Patient Parameters

Program Overview

This study is testing a combination of treatments for recurrent glioblastoma, a brain tumor that has come back or is growing despite earlier treatment. The treatments being studied are pembrolizumab, olaparib, and temozolomide. Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer. Olaparib is a drug that stops cancer cells from repairing themselves, and temozolomide is a chemotherapy drug that damages cancer cell DNA. The study aims to find out if these drugs, used together, can help control glioblastoma.

Description

This trial is open to adults with recurrent glioblastoma, a type of brain tumor that has returned or is growing after previous treatment. The study will test the safety and effectiveness of a combination of drugs: pembrolizumab, olaparib, and temozolomide. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. Olaparib prevents cancer cells from repairing their DNA, and temozolomide is a chemotherapy drug that damages cancer cell DNA.

Participants will receive pembrolizumab for up to two years, as long as they do not experience serious side effects and their cancer does not worsen. Some participants will also receive olaparib and temozolomide. The study will include about 66-78 participants.

The study is supported by Merck Sharp & Dohme Corp., which is providing funding and the study drugs pembrolizumab and olaparib.

Participants will undergo screening to determine eligibility, and the study will include regular evaluations and follow-up visits. The U.S. Food and Drug Administration (FDA) has approved temozolomide for glioblastoma, but pembrolizumab and olaparib are not yet approved for this specific use, although they are approved for other conditions.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must be able to follow the treatment schedule and keep a medication diary.
  • Must be at least 18 years old.
  • Women must not be pregnant or breastfeeding.
  • Must have a good performance status, meaning they are able to carry out daily activities.
  • Must be able to swallow pills.
  • Must have a specific type of glioblastoma confirmed by tests.
  • Must be at the first or second relapse of glioblastoma.
  • Must show tumor progression on an MRI scan.
  • Must have a recent MRI scan.
  • Must have enough tissue from a previous surgery for study purposes.
  • Must have surgically removable disease if in Cohort 2.
  • Must have recovered from previous treatments.
  • Must have adequate blood counts and organ function based on lab tests.
  • Must not have other active cancers that require treatment.
  • Women of childbearing potential must use contraception and have a negative pregnancy test.
  • Men must agree to use contraception and not donate sperm during the study.

Exclusion Criteria

  • Cannot have certain genetic mutations or tumor locations.
  • Cannot have received certain previous treatments, like PARP inhibitors or specific immunotherapies.
  • Cannot be on high-dose steroids or certain other medications.
  • Cannot have active infections or other serious health conditions.
  • Cannot have a history of certain heart conditions or other serious illnesses.
  • Cannot be pregnant or breastfeeding.
  • Cannot have received a live vaccine recently.
  • Cannot have certain gastrointestinal issues that affect drug absorption.

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