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 advanced brain tumour (Grade 4 glioblastoma or related Grade 4 brain tumours confirmed by tissue testing), as classified under medical guidelines from 2016 or 2021.
• People who have agreed to be part of the Minderoo Precision Brain Tumour Programme and have had detailed genetic testing of their tumour completed (whole genome and transcriptome data available).
• People in the relapsed group whose tumour has come back for the first time after completing surgery and standard chemotherapy-with-radiation treatment, and whose tumour can be measured or assessed on scans.
• People in the frontline group who have finished surgery and standard chemotherapy-with-radiation treatment and whose tumour has not yet returned, as long as all other criteria are met.
• People aged 16 years or older.
• People with a life expectancy of at least 12 weeks.
• People who are largely able to care for themselves and carry out light activity, as measured by a standard medical performance scale (WHO performance status 0–1).
• People whose neurological symptoms (such as weakness or coordination problems) have been stable, with no worsening and no need for increasing steroid doses in the week before joining.
• People who are willing and able to give written informed consent and to attend treatment and follow-up appointments.
• People whose blood counts and organ function results fall within the required ranges when tested within one week before starting the trial (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 150 days after the last dose of either study drug.

Who may not be able to join:

• People who have received certain cancer treatments too recently before starting — including standard chemotherapy within the past 2 weeks (or 6 weeks for a specific type called nitrosoureas), a drug called bevacizumab within the past 6 weeks, or other investigational or approved medicines within a timeframe based on how long those drugs stay active in the body.
• People who have previously received immune checkpoint inhibitor therapy, cancer vaccines, or certain targeted drugs called BRAF or MEK inhibitors (prior use of other immune-modifying treatments must be discussed with the trial team).
• People who are still experiencing side effects of grade 2 or higher from previous treatments or existing conditions (confirm grading with trial site).
• People whose tumour 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 in or around the tumour on their most recent MRI scan, unless the findings have been stable on at least two MRI scans taken at least 3 weeks apart.
• People with a history of significant bleeding disorders, including serious gastrointestinal bleeding within the past 6 months.
• People with a history of a blood clot in an artery.
• People who have had a deep vein thrombosis, pulmonary embolism, or other significant blood clot within the past 3 months (people with a clot more than 3 months ago who are on stable blood thinners may still be considered, though those on Warfarin would need to switch to a different type of blood thinner).
• People with a history of certain heart conditions, including a heart attack or significant heart failure within the past 6 months, or an abnormal heart rhythm finding on an ECG at screening.
• People with conditions affecting how the gut absorbs medicines, including inflammatory bowel disease, pancreatitis, a history of bowel perforation or fistula, or a condition called Gilbert's syndrome.
• People with certain eye conditions, including glaucoma, retinal vein occlusion or risk factors for it (such as uncontrolled high blood pressure or uncontrolled diabetes), certain retinal problems, high pressure inside the eye, or certain corneal conditions.
• People whose urine shows high levels of protein (more than 1g in a 24-hour urine collection).
• People with significant lung disease, including certain types of lung inflammation, scarring, cystic fibrosis, active tuberculosis, or a history of specific opportunistic infections.
• People who have tested positive for hepatitis B, hepatitis C, or HIV.
• People who require more than 3mg of dexamethasone (a steroid) per day to control neurological symptoms (people on a stable dose at or below this level for at least 5 days before starting may still be considered).
• People who have received a live vaccine within the 30 days before starting the trial (inactive vaccines, including COVID-19 vaccines, are permitted if given at least one week before starting).
• People who currently have another active cancer (people who were treated for a previous cancer, have had no signs of it returning for 3 or more years, and are considered at very low risk of recurrence may still be considered).
• People who are already taking part in another interventional clinical trial, or who plan to do so while on this trial (participation in an observational study only would be acceptable).
• People who have taken certain medications, supplements, herbal remedies, or foods within 14 days before starting that could interfere with how the study drugs work in the body (confirm specific substances with the trial site).
• People who have had major surgery within the past 4 weeks, minor surgery within the past 2 weeks, or palliative radiotherapy within the past 1 week before starting the trial.
• People whom the trial doctor considers unsuitable for the trial for any other medical reason.

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