Study on Nivolumab with Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma

Inclusion Criteria

• Diagnosed with glioblastoma, a type of brain cancer, confirmed by specific lab tests.
• Tumor must have a specific genetic marker called MGMT hypermethylation.
• Have had surgery to remove as much of the tumor as possible.
• Previously treated with radiation and the chemotherapy drug temozolomide.
• Evidence of the cancer returning, either through scans or pathology.
• Tumor size must be 5 cm or smaller in its largest dimension.
• Have had one previous round of radiation therapy.
• Be 18 years or older.
• Be in good overall health, with a performance status score of 70% or higher.
• Have adequate blood cell counts and organ function, including:
  • Hemoglobin level of at least 10 g/dL.
  • Neutrophil count of at least 1,500/mm³.
  • Lymphocyte count of at least 200/mm³.
  • Platelet count of at least 100,000/mm³.
• Have adequate liver function, with specific enzyme levels within normal limits.
• Have adequate kidney function, with blood urea nitrogen (BUN) and creatinine levels within normal limits.

Exclusion Criteria

• Tumor located in certain areas of the brain.
• Glioblastoma with a specific IDH mutation.
• More than one recurrence of the tumor after initial treatment.
• Radiation to the brain within the last 4 months.
• Tumor larger than 5 cm in its largest dimension.
• Recent blood clots in the lungs or deep veins.
• Severe heart failure or recent heart attack.
• Recent serious stomach or abdominal issues.
• Non-healing wounds or fractures.
• History of bleeding in the brain.
• Uncontrolled high blood pressure.
• Need for high doses of steroids to manage the disease.
• Previous treatment with certain immune therapies or bevacizumab.
• Allergies to nivolumab or bevacizumab.
• Immune system deficiencies, including HIV or AIDS.
• Active hepatitis B or C infections.
• History of active tuberculosis.
• Other active cancers requiring treatment.
• Active autoimmune diseases needing treatment in the past 2 years.
• History of lung inflammation not caused by infection.
• Active infections needing treatment.
• Pregnant or breastfeeding, or planning to conceive during the study.
• Unable to have an MRI scan due to medical devices or other reasons.