Phase 3 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 who have been diagnosed with a specific type of brain tumour called glioblastoma (IDH-wildtype), confirmed by a pathology test and classified according to 2021 WHO guidelines.
• People whose glioblastoma has come back or grown for the first time after initial treatment, as shown on brain scans, and where that growth was detected at least 3 months after finishing radiation therapy.
• People who received first-line treatment that may have included certain anti-cancer medicines (but not a drug type called nitrosoureas), tumour-treating fields (a device-based therapy), or a course of radiation therapy of at least 15 sessions.
• People whose brain scans — specifically a specialised PET scan using a tracer called FET, combined with an MRI — show increased activity clearly linked to the tumour area, as confirmed by a central review team.
• People who have had surgery to remove as much tumour as possible for the recurrence, and who still have measurable tumour remaining on scans taken 4–6 weeks after that surgery.
• People aged 18 or older.
• People who are able to understand the study and are willing to follow all study requirements.
• People who are in reasonably good general health, as measured by a standard medical scoring system (ECOG performance score of 0–2, or a Karnofsky score of 70 or above).
• People who have been on a stable or reducing dose of steroid medication for at least the 7 days before joining the study.
• People whose blood, liver, and kidney function meet required levels at the time of screening.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the study drug, must not be breastfeeding, and must agree to use a highly effective form of contraception during treatment and for 6 months after the last dose.
• Male participants must agree to use condoms during sex throughout treatment and for 3 months after the last dose, must not donate sperm during treatment or for 6 months after the last dose, and — if their partner could become pregnant — that partner must also use a highly effective form of contraception during treatment and for 6 months after the last dose.

Who may not be able to join:

• People who have had external beam radiation to the brain within the past 3 months, or who have previously had a type of internal radiation treatment called brachytherapy to the brain.
• People who have been treated with a drug called bevacizumab within the past 6 weeks.
• People who have a known allergy or medical reason to avoid the PET imaging tracer, contrast dye used in scans, or MRI scanning — including those with certain implanted medical devices.
• People who are unable to lie still for at least 20 minutes, or who would need general anaesthesia to complete the MRI or PET scans.
• People with a history of certain long-term infections that involve a specific immune reaction, such as tuberculosis, or widespread fungal or parasitic infections.
• People whose tumour has grown on scans alongside a noticeable decline in their health, and whose life expectancy is estimated to be less than 3 months.
• People with certain blood clotting conditions that would make catheter insertion or other procedures unsafe (confirm with trial site).
• People who have had a significant illness or relevant physical injury within the 2 weeks before starting the study drug.
• People with known liver or kidney disease, such as hepatitis, cirrhosis, or kidney failure.
• People with serious ongoing or active infections — including active tuberculosis, hepatitis B, or hepatitis C — that require systemic (whole-body) treatment.
• People who are still experiencing significant side effects (above a certain severity level) from previous cancer treatments.
• People who have taken part in another clinical trial involving an experimental treatment within the past 90 days.
• People who are not expected to be able to comply with stays in a specialised nuclear medicine ward as required by local regulations.
• People with a condition called phenylketonuria (PKU), a rare metabolic disorder.
• People with any other condition that, in the opinion of the study doctor, could make participation unsafe or affect the study results.

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