Multicenter Study to Find Best Atezolizumab Biomarkers for Recurrent Glioblastoma: The MOAB Trial

Sponsor: Duke University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06069726

Provider View

This study is exploring whether the drug atezolizumab can help patients with recurrent glioblastoma, a type of brain cancer, especially those with a low number of genetic mutations in their tumors.

Patient Parameters

Program Overview

Glioblastoma is a challenging brain cancer with limited treatment options and poor survival rates. This study is testing if the drug atezolizumab, given before surgery, can benefit patients whose glioblastoma has returned and who have a low number of mutations in their tumors. Researchers are examining how the immune system interacts with glioblastoma and whether certain genetic factors can predict a better response to this treatment. The goal is to improve the effectiveness of immunotherapy for glioblastoma patients.

Description

Glioblastoma is a tough cancer to treat, and current therapies often don't work well, with less than 20% of patients surviving two years. Immune checkpoint inhibitors like atezolizumab might help, but they haven't been fully tested in this setting. The relationship between the immune system and glioblastoma is complex, and some factors that predict good responses in other cancers might not work the same way here. Atezolizumab has shown promise, especially in patients with a low number of mutations in their tumors, which might indicate a better immune response. This study will test if giving atezolizumab before surgery can help these patients. Researchers will also study tumor samples to understand how low mutation levels relate to immune responses. The aim is to make immunotherapy more effective for glioblastoma patients.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older.
  • Confirmed diagnosis of glioblastoma (GBM), IDH wild-type.
  • Evidence of first or second recurrence after radiation and chemotherapy with temozolomide (TMZ).
  • Available tissue sample from the initial diagnosis.
  • Adequate organ function, including:
    • Hemoglobin of at least 9 g/dl.
    • Platelet count of at least 75,000/µl.
    • Neutrophil count of at least 1000 cells/mm3.
    • Creatinine within 1.5 times the normal limit.
    • Total bilirubin within 1.5 times the normal limit, with exceptions for Gilbert's Syndrome.
    • Alkaline phosphatase (ALP) within 2.5 times the normal limit.
    • AST and ALT within 2.5 times the normal limit.
    • Serum albumin of at least 25 g/L.
    • Normal blood clotting times.
  • Karnofsky Performance Status (KPS) of 70% or higher.
  • Agreement to use effective birth control methods if of childbearing potential.
  • Signed informed consent form.
  • Negative HIV test, unless stable on treatment with a CD4 count over 200/µL and undetectable viral load.
  • Negative hepatitis B and C tests, with specific conditions for those with past infections.

Exclusion Criteria

  • Pregnant or breastfeeding, or planning to become pregnant during treatment or within 5 months after.
  • Previous treatment with immunotherapy.
  • Recent treatment with bevacizumab or systemic immunosuppressive medication, with some exceptions.
  • Severe allergic reactions to similar drugs.
  • Active autoimmune disease or immune deficiency, with some exceptions.
  • Less than 12 weeks from radiation therapy, unless specific conditions are met.
  • Contraindication to surgery.
  • Significant heart disease or recent major surgery.
  • Recent history of other cancers, with some exceptions.
  • Severe infection or recent live vaccine.
  • Participation in another clinical trial or investigational therapy recently.
  • Uncontrolled fluid buildup or high calcium levels.
  • Active tuberculosis or certain lung diseases.
  • Recent antibiotic treatment, with some exceptions.
  • Previous stem cell or organ transplant.

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