Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who have been confirmed by tissue testing to have a brain tumour classified as one of the following: a progressive or returning WHO grade IV glioblastoma (IDH wildtype, including molecular glioblastoma and gliosarcoma), or a WHO grade 4 astrocytoma with an IDH mutation
• People whose tumour is considered suitable for surgical removal
• People whose tumour can be measured or assessed using standard brain tumour response guidelines (confirm with trial site)
• People who are willing to undergo a biopsy followed by surgical tumour removal at Mayo Clinic in Rochester, Minnesota
• People with a general health and functioning level that meets the trial's standards — rated as 0, 1, or 2 on one scale, and at least 60 on another (confirm with trial site), assessed within 7 days before the first study treatment
• People with blood counts and organ function results (from tests taken within 15 days before joining) that fall within the trial's required ranges for red blood cells, white blood cells, platelets, kidney function, liver function, and pancreas-related enzymes
• People with a heart pumping function of at least 50%, confirmed within 29 days before joining
• People who could become pregnant must have a negative pregnancy test within 8 days before joining
• People who could become pregnant or father a child must be willing to use reliable contraception from the first dose until 180 days after the last dose
• People willing to sign a consent form agreeing to take part
• People willing to provide blood samples for research purposes
• People willing to provide tissue samples for research purposes
• People willing to consent to having tissue, spinal fluid, and/or blood samples stored in a research collection
• People willing to return to the enrolling site for follow-up visits during the active monitoring period of the study

Who may not be able to join:

• People who are pregnant
• People who are currently breastfeeding
• People who could become pregnant or father a child and are unwilling to use reliable contraception
• People showing signs of a life-threatening build-up of pressure in the brain (such as severe headaches, nausea, or decreasing consciousness) that means surgery cannot be safely delayed by 4–7 days
• People who received the drug bevacizumab (Avastin) within 30 days before joining
• People whose steroid (dexamethasone) dose has been increasing before joining, or who are currently taking more than 4 mg per day
• People who received chemotherapy within 30 days before joining
• People who received a live vaccine within 30 days before joining
• People who have not yet recovered from side effects of major surgery within 28 days before joining, or radiation therapy within 14 days before joining
• People with serious other illnesses or conditions that, in the treating doctor's judgement, would make participation unsafe or affect how results are assessed
• People with uncontrolled ongoing conditions including active infections requiring intravenous antibiotics, heart failure with symptoms, unstable chest pain, irregular heart rhythms, or mental health or social situations (such as active drug addiction) that could make it difficult to follow the study's requirements
• People currently taking part in another clinical trial using an investigational treatment
• People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for dangerous heart rhythm problems
• People with an active autoimmune disease that required systemic medical treatment within the past 2 years (note: routine hormone or supplement replacement therapies are not considered systemic treatment for this purpose)
• People with both active hepatitis B and active hepatitis C at the same time — though people with only one of these conditions may still be eligible if certain criteria are met (confirm with trial site)
• People with a known history of active tuberculosis (TB)
• People with a history of lung inflammation or scarring (not caused by infection) that required steroid treatment, or who currently have such a condition
• People with a known allergy or sensitivity to pembrolizumab, IL-2, GI-102, or any of their ingredients
• People who have previously received a transplant of tissue or a solid organ from another person

Important: Always verify eligibility with the trial site directly before applying.