Study on Nivolumab and Ipilimumab for Treating Aggressive Pituitary Tumors

Inclusion Criteria

• Be 18 years or older.
• Have a pituitary tumor that cannot be removed by surgery, or a pituitary carcinoma.
• Tumor must have shown growth on scans after radiation treatment.
• Have measurable disease according to specific medical criteria.
• At least four weeks must have passed since the last dose of the chemotherapy drug temozolomide, and blood counts must have recovered from any previous chemotherapy.
• Have a Karnofsky Performance Status (KPS) score of 70 or higher, indicating the ability to care for oneself and carry out normal activities.
• Meet specific blood test criteria, including:
  • White blood cell count of at least 2000/uL.
  • Neutrophil count of at least 1500/uL.
  • Platelet count of at least 100,000/uL.
  • Hemoglobin level above 9.0 g/dL.
  • Liver enzymes (AST/ALT) no more than three times the upper limit of normal.
  • Total bilirubin no more than 1.5 times the upper limit of normal, except for those with Gilbert Syndrome.
• Have normal kidney function as indicated by specific blood tests.
• Women of childbearing potential must use effective birth control during the study and for 23 weeks after the last dose of the study drug.
• Men who are sexually active with women of childbearing potential must use effective birth control during the study and for 31 weeks after the last dose of the study drug.

Exclusion Criteria

• Need for more than 4 mg per day of the steroid dexamethasone or an equivalent dose.
• Have an active or recent autoimmune disease, except for certain conditions like vitiligo or type I diabetes.
• Have previously been treated with a CTLA-4 antibody.
• Have a history of hepatitis B or C infection.
• Have a history of HIV or AIDS.
• Have allergies to the study drugs or severe reactions to any monoclonal antibody.
• Be pregnant or breastfeeding.
• Unable to undergo regular imaging scans to monitor the tumor.