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:

• People aged 18 or older.
• People who have been diagnosed (confirmed by tissue testing) with a specific type of aggressive brain tumour called Grade IV IDH wildtype glioblastoma (including types called molecular glioblastoma and gliosarcoma) that has come back or kept growing.
• People who have already received standard treatments, including surgery or biopsy, radiation therapy, and a chemotherapy drug called temozolomide.
• People who have a tumour visible on an MRI scan that a brain surgeon has assessed as able to be operated on or biopsied.
• People who are willing to have a clinically indicated biopsy and/or surgery at Mayo Clinic in Rochester, Minnesota.
• People with a good general level of physical functioning, as measured by standard medical scoring tools (confirm with trial site).
• People whose recent blood tests (taken within 15 days before joining) show that blood cell counts, kidney function, liver function, and blood clotting levels are within acceptable ranges for the trial.
• People who test negative for pregnancy within 7 days before joining (applies to those who could become pregnant).
• People who are able to father a child, or those who could become pregnant, who are willing to use reliable contraception starting from the first dose until 180 days after the last dose.
• People who are willing to return to the enrolling site for follow-up visits during the active study period.
• People who are willing to provide tissue and blood samples for research purposes.
• People who have given written informed consent to participate.

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People who could become pregnant or father a child and are not willing to use adequate contraception during the trial.
• People showing signs of a life-threatening increase in pressure in the brain (such as severe headache, nausea, or decreasing consciousness) that require immediate surgery, with no ability to wait 4–7 days.
• People who received a treatment called bevacizumab (Avastin) within the 4 months before joining (note: bevacizumab may be allowed during a later phase of the study for symptom control).
• People who received a live vaccine within 30 days before joining.
• People who require more than 2mg per day of a steroid called dexamethasone within 2 days before joining.
• People who have not yet recovered from side effects of major surgery performed within 28 days before joining, or radiation therapy within 14 days before joining.
• People with serious other illnesses or conditions that, in the opinion of the medical team, would make participation unsafe or affect the assessment of the trial treatments.
• People with a known history of HIV infection.
• People with uncontrolled ongoing illness, including active infection, certain heart conditions, or psychiatric or social situations that would make it difficult to follow the study requirements.
• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who have had another active cancer requiring systemic treatment within the past year.
• People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for life-threatening heart rhythm problems.
• People who have had an active autoimmune disease requiring systemic medical treatment within the past 2 years (note: standard hormone or replacement therapies are not considered systemic treatment for this purpose).
• People who have both active Hepatitis B and active Hepatitis C at the same time (people with only one of these may still be eligible if certain conditions are met — confirm with trial site).
• People with a known history of active tuberculosis (TB).
• People with a history of, or current, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People with a known allergy or hypersensitivity to the study drug pembrolizumab or any of its ingredients.
• People who received a type of immunotherapy drug (anti-PD-1, anti-PD-L1, or anti-PD-L2 treatment) within the 12 months before joining.
• People who have had an organ or tissue transplant from another person.

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