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 who have been diagnosed with a specific type of brain tumour called glioblastoma (IDH-wildtype Grade 4), confirmed through laboratory testing of tumour tissue.
• People who have had their tumour's genetic information (whole genome and transcriptome data) analysed through the Minderoo Precision Brain Tumour Programme, or who are able to enrol in that programme at the same time as joining this trial.
• People in the minimal residual disease group who have completed surgery and a standard course of combined chemotherapy and radiation treatment (called Stupp protocol), and whose disease has not shown signs of returning on scans after that treatment.
• People who are able to start the trial no later than 6 weeks after finishing their chemoradiotherapy.
• People aged 16 or older.
• People with a life expectancy of at least 12 weeks.
• People who are generally well and able to carry out everyday activities with little or no difficulty (rated 0 or 1 on the WHO performance scale).
• People whose neurological symptoms are stable and who have not needed increasing doses of steroid medication in the week before starting the trial.
• People who are able to give written informed consent and are able to participate in treatment and follow-up.
• People whose blood test results fall within the required ranges for red blood cells, white blood cells, platelets, liver function, kidney function, blood sugar, salt levels, and urine protein — tested within one week before the first dose (confirm specific values with the trial site).
• Women who could become pregnant must have a negative blood pregnancy test within 14 days before starting the trial.
• People of childbearing potential who agree to use a highly effective form of contraception during the trial and for at least 180 days after the last dose of either study drug.

Who may not be able to join:

• People who have recently received certain treatments too close to the trial start date, including: the drug bevacizumab within the past 6 weeks, any other experimental drug since their diagnosis, or tumour treating fields therapy within the past 6 weeks.
• People who have previously received immunotherapy treatments such as immune checkpoint inhibitors or cancer vaccines (prior use of other immune-related experimental treatments must be discussed with the trial team).
• People who still have moderate or severe side effects (Grade 2 or higher) from a previous condition or prior treatment.
• People whose cancer has spread to the membranes surrounding the brain or spinal cord, or to the brain stem or spinal cord itself.
• People who have signs of recent bleeding within or around their tumour on an MRI scan, unless the finding has been stable on at least two MRI scans taken at least 3 weeks apart.
• People with a history of significant bleeding disorders, including a serious gastrointestinal bleed in the past 6 months.
• People with a history of a blood clot in an artery.
• People who have had a significant blood clot in a vein (such as a deep vein thrombosis or a clot in the lungs) within the past 3 months. People with a clot more than 3 months ago who are on stable blood-thinning medication may still be considered.
• People with a history of significant heart problems, including a heart attack or moderate-to-severe heart failure within the past 6 months, or certain abnormal heart rhythm findings on an ECG at the screening stage.
• People with conditions that affect the absorption of food or medication through the gut, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or a history of a hole or abnormal opening in the gut (perforation or fistula).
• People with uncontrolled diabetes. People with controlled diabetes and a blood sugar (HbA1C) level below 8% may still be considered.
• People whose urine protein level is greater than 1g over 24 hours (those with a borderline result on a urine dipstick test will need a 24-hour urine collection to check this more precisely).
• People with serious lung conditions such as pneumonitis, pulmonary fibrosis, cystic fibrosis, active tuberculosis, or a history of certain serious lung infections.
• People who test positive for hepatitis B, hepatitis C, or HIV.
• People who need more than 3mg of dexamethasone (a steroid) per day to manage neurological symptoms. People on a stable dose at or below this level for at least 5 days before the trial start may still be considered.
• People who have received a live vaccine within 30 days before the planned trial start date. Inactive vaccines (including COVID-19 vaccines) are permitted if given more than one week before the trial start.
• People who currently have or are being treated for another active cancer. People who were treated for a previous cancer, have had no signs of it returning for three or more years, and are considered at very low risk of it coming back may still be considered.
• People who are already taking part in, or plan to take part in, another interventional clinical trial at the same time. Participation in an observational study (where no treatment is given) would be acceptable.
• People taking certain medications, supplements, herbal remedies, or foods that could interact with the study drugs (particularly substances that strongly affect a liver enzyme called CYP3A4), within 14 days before starting the trial or during treatment (confirm details with the trial site).
• People who have had major surgery within the past 4 weeks, or minor surgery within the past 2 weeks (not including the placement of a vascular access device).
• People who have received a live or attenuated (weakened) vaccine within 4 weeks before the trial start, or who would need one during the trial.
• People who, in the opinion of the trial doctor, would not be suitable candidates for the trial for any other reason.

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