Study on Pembrolizumab and M032 for Treating Recurrent Malignant Brain Tumors

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05084430

Provider View

This clinical trial is testing the safety and effectiveness of combining Pembrolizumab, an immunotherapy drug, with M032, a modified virus designed to attack cancer cells, in patients with recurrent malignant brain tumors like glioblastoma.

Patient Parameters

Program Overview

This study aims to confirm the safety and tolerability of using Pembrolizumab together with M032, a modified virus that targets cancer cells, in patients with recurrent malignant brain tumors such as glioblastoma. The trial will determine the best dose of M032 to use alongside Pembrolizumab to treat these tumors.

Description

The trial is divided into several phases to test the combination of Pembrolizumab and M032 in patients with recurrent malignant brain tumors. In the first phase, patients whose tumors have returned after initial treatments will receive M032 directly into the tumor area during surgery. The goal is to find the safest dose of M032 to use with Pembrolizumab. If the initial dose causes side effects, the dose will be adjusted.

In the next phase, patients with newly diagnosed malignant brain tumors will be treated with the established safe dose of M032 and Pembrolizumab. The treatment involves surgery to remove the tumor, followed by injections of M032 into the tumor area and regular doses of Pembrolizumab.

The study will monitor patients for side effects and how well the treatment works in shrinking the tumors. If the treatment is effective, patients may receive additional doses. The trial aims to improve treatment options for patients with these aggressive brain tumors.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of glioblastoma, anaplastic astrocytoma, or gliosarcoma.
  • Tumor must have returned after previous treatments like surgery, radiation, and chemotherapy.
  • Must be a candidate for surgery to remove the tumor.
  • Must be 18 years or older.
  • Must have a life expectancy of more than 4 weeks.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for six months after the last dose.
  • Must be able to understand and sign a consent form.
  • Women must not be pregnant, confirmed by a pregnancy test before starting treatment.
  • Steroid use is allowed if the dose has not increased within two weeks of M032 administration.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received previous treatments with certain immunotherapy drugs.
  • Have received other cancer treatments within four weeks before starting the study.
  • Have received a live vaccine within 30 days before the first dose of the study drug.
  • Have a diagnosis of immunodeficiency or are on high-dose steroid therapy.
  • Have another active cancer that required treatment in the past three years.
  • Have severe allergies to Pembrolizumab or its ingredients.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have a history of lung inflammation or current lung issues.
  • Have active infections requiring treatment.
  • Have a history of HIV, Hepatitis B, or active Hepatitis C.
  • Have a history of tuberculosis.
  • Have any condition that might interfere with the study results or participation.
  • Have psychiatric or substance abuse disorders affecting cooperation with the study.
  • Have had recent chemotherapy, immunotherapy, or surgery within four weeks before the study.
  • Have a history of allergic reactions to similar drugs or IL-12.
  • Have tumors requiring treatment in sensitive brain areas.
  • Have a history of brain infections or multiple sclerosis.
  • Have active herpes lesions.
  • Are on medications against herpes viruses.
  • Have uncontrolled illnesses like heart failure or unstable angina.
  • Have allergies to IV contrast material not manageable by pre-treatment.
  • Have certain medical devices like pacemakers or metal fragments.
  • Have received certain therapies like Gliadel or Bevacizumab recently.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.