Study on GI-102 Alone or With Pembrolizumab Before Surgery for Treating Recurrent or Worsening Brain Tumors

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of specific aggressive brain tumors that have returned or are worsening.
• Be a candidate for surgery to remove the tumor.
• Have measurable or non-measurable disease as per specific medical criteria.
• Be willing to undergo a biopsy and surgery at Mayo Clinic in Rochester, MN.
• Have a performance status score indicating good overall health.
• Meet specific blood test requirements for hemoglobin, neutrophil count, platelet count, kidney and liver function.
• Have a heart function of at least 50%.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
• Be willing to provide blood and tissue samples for research.
• Agree to return for follow-up visits during the study.

Exclusion Criteria

• Pregnant or nursing women, or those not willing to use contraception.
• Have severe symptoms of increased brain pressure that require immediate surgery.
• Have received certain treatments like bevacizumab, chemotherapy, or live vaccines recently.
• Have not recovered from side effects of previous treatments like surgery or radiation.
• Have serious health conditions that could interfere with the study.
• Have active infections or heart conditions that are not well-controlled.
• Be taking other investigational drugs.
• Have a history of heart attack or severe heart failure recently.
• Have active autoimmune diseases requiring treatment in the past two years.
• Have active hepatitis B or C infections unless well-controlled.
• Have a history of tuberculosis or lung diseases requiring steroids.
• Be allergic to pembrolizumab, IL-2, GI-102, or similar drugs.
• Have had a tissue or organ transplant.