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 glioblastoma (a type of brain tumour), confirmed by laboratory analysis of tumour tissue or cells, according to 2021 World Health Organization classification, whose tumour has clearly come back for the first time after completing standard treatment (6 weeks of radiation therapy combined with the chemotherapy drug temozolomide, followed by further temozolomide).
• People who finished the combined radiation and chemotherapy phase of treatment at least 3 months before joining the trial.
• People whose steroid dose has been stable or decreasing for at least 7 days before the baseline brain scan, and who are taking no more than 4 mg per day of dexamethasone (or an equivalent steroid) at the time of joining.
• People who have not had surgery or other major invasive procedures within 4 weeks before registration, and no minor procedures such as a core biopsy within 7 days before registration (placement of a central vascular access device at least 2 days before starting trial treatment is permitted).
• People who need anti-seizure medication and are already taking, or can switch to, a type that does not affect certain liver enzymes (called non-enzyme-inducing antiepileptic drugs), with the switch completed at least 2 weeks before registration.
• People whose brain tumour can be measured on a recent MRI scan (done within 28 days before registration), with at least one area of tumour that is at least 10 mm in size and visible on two or more scan slices.
• People with a Karnofsky performance status score of 70–100, meaning they are able to care for themselves and carry out normal activities with at most minor assistance (confirm with trial site).
• People whose blood counts are within acceptable ranges — specifically, neutrophils at or above 1.5 × 10⁹/L, platelets at or above 100 × 10⁹/L, and haemoglobin at or above 90 g/L.
• People whose liver function blood test results are within acceptable ranges as specified by the trial (confirm with trial site for exact values).
• People whose kidneys are functioning at or above a certain level, measured by a formula called CKD-EPI, giving a result of at least 45 mL/min/1.73 m².
• People whose urine protein levels are within acceptable limits (a urine test showing less than 2+ protein, or if 2+ or higher, a 24-hour urine collection showing no more than 1 g of protein).
• People whose blood clotting function is within an acceptable range, and if taking blood-thinning medication, have been on a stable dose for at least two weeks before registration with clotting levels within the therapeutic range.
• Women who could become pregnant must not be pregnant or breastfeeding, must have a negative pregnancy test before joining, and must agree to use highly effective contraception during the trial and for 6 months after the last dose of the trial drug.
• Men must agree not to donate sperm or father a child during the trial and for 6 months after the last dose of the trial drug.
• People who are able and willing to swallow the trial drug as a whole tablet.

For Cohort 2 only (a specific group within the trial):

• People who have a medical reason to undergo neurosurgical removal of their recurrent tumour, and who agree to allow part of the removed tumour tissue and a sample of cerebrospinal fluid (the fluid around the brain and spine) to be used for research, provided enough tissue remains for standard diagnostic analysis.

Who may not be able to join:

• People whose glioblastoma has come back more than once, or who have received more than one course of chemotherapy (beyond the standard combined and follow-up temozolomide treatment).
• People who have an enlarged prostate causing difficulty urinating, or a type of glaucoma called angle-closure glaucoma.
• People who have taken another experimental drug within 30 days before registration.
• People currently taking certain antidepressant medications (including tricyclic antidepressants, SSRIs, or SNRIs) who are not able to switch to the antidepressant used in this trial (trimipramine); those on fluoxetine specifically must have stopped taking it at least two months before starting trial treatment.
• People who have previously been treated with atezolizumab or any other immune checkpoint inhibitor drug.
• People who have previously been treated with bevacizumab or similar drugs that target blood vessel growth (VEGF inhibitors).
• People who have taken immunosuppressive medications (drugs that reduce immune system activity) within a recent period before registration, with the exception of certain inhaled or nasal steroid sprays.
• People with a life expectancy of less than 12 weeks.
• People with another currently active cancer, except for certain skin cancers or cervical carcinoma in situ that were fully treated with curative intent at least 2 years before registration with no signs of recurrence.
• People who require three or more blood pressure medications to control their blood pressure, or whose blood pressure remains poorly controlled despite appropriate medication.
• People with serious heart conditions, including severe heart failure, unstable chest pain, a heart attack in the past 6 months, or serious heart rhythm problems requiring medication (with some exceptions — confirm with trial site).
• People with a certain type of abnormal heart electrical reading (QTcF interval of 450 milliseconds or more), or other risk factors for heart rhythm problems such as low potassium or a family history of long QT syndrome.
• People with a significant electrical conduction problem in the heart called a grade 3 atrioventricular (AV) block, detected on an ECG.
• People who have had a stroke or bleeding in the brain within the 6 months before registration.
• People with a known history of HIV, or active hepatitis B or C infection, or any uncontrolled infection currently requiring intravenous antibiotic or antiviral treatment.
• People with a known history of tuberculosis, a primary immune system disorder, or an organ transplant from another person; or people who have received a live vaccine within 28 days before the first dose of atezolizumab (inactivated vaccines such as the flu shot are permitted).
• People with a current or past autoimmune disease, with the exception of well-controlled type 2 diabetes or well-controlled underactive thyroid managed with medication.
• People currently taking certain medications that strongly affect how the liver processes drugs (CYP3A or CYP2D6 inducers or inhibitors — confirm with trial site for a full list).
• People taking any other medication that is contraindicated (not safe to use) with the trial drugs.
• People taking a class of medications called monoamine oxidase inhibitors (MAOIs), or who have not stopped these medications at least 14 days before starting the trial's antidepressant drug.
• People with a known allergy or sensitivity to the trial drugs or any of their components.
• People with serious medical, psychiatric, psychological, family, or logistical circumstances that, in the treating doctor's judgement, could interfere with participation in the trial (confirm with trial site).

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