Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 are able to understand the study and are willing to sign a written consent form.
• People who are able to follow the visit and dosing schedule, and are willing to keep an accurate daily diary of when they take their medication.
• People who are at least 18 years old at the time of signing the consent form.
• Women of childbearing potential who are not currently pregnant or breastfeeding.
• People who are in reasonably good physical condition, as measured by standard performance scales used in cancer care (confirm specific score requirements with the trial site).
• People who are able to swallow tablets or capsules.
• People who have been diagnosed with a specific type of aggressive brain tumour called Grade IV IDH wildtype glioblastoma (or certain closely related variants), confirmed through laboratory testing of tumour tissue.
• People whose glioblastoma has come back for the first or second time, meaning they have had no more than two prior treatments (for example, radiation with or without chemotherapy, and one further treatment after the tumour first returned).
• People whose brain scans (MRI) clearly show the tumour has grown or progressed, based on established criteria used in brain tumour research.
• People who have had an MRI scan within the 14 days before enrolling in the study.
• People for whom stored tumour tissue from a previous surgery is available for laboratory analysis (the amount of tissue required depends on which group of the trial a person would join — confirm details with the trial site).
• People in the surgical group of the trial (Cohort 2 only) whose tumour can be safely operated on, with enough tumour tissue available for removal and analysis.
• People who have waited at least 12 weeks after finishing radiation therapy before starting the study drug, unless laboratory testing clearly confirms the tumour has grown back.
• People who have recovered from the significant side effects of previous treatments to a mild or pre-treatment level (with some exceptions such as hair loss and certain blood count changes, which are common after chemotherapy).
• People who have waited at least 4 weeks after a major brain surgery, or at least 1 week after a minor brain biopsy, before joining the study.
• People who have waited appropriate time periods after their most recent previous treatments before starting the study (the exact waiting period depends on the type of treatment received — confirm with the trial site).
• People whose blood test results show their organs (such as bone marrow, liver, and kidneys) are working well enough, based on tests done within 10 days before starting the study drug (specific values will be checked by the trial site).
• People who have had another cancer in the past, but only if that cancer is not currently active or requiring treatment — certain minor skin cancers or early-stage cancers that have been treated may still be eligible (confirm with trial site).
• Male participants who agree to use contraception during the treatment period and for at least 180 days after the last dose, and who agree not to donate sperm during that time.
• Female participants of childbearing potential who agree to use contraception during the treatment period and for at least 120 days after the last dose, and who have a negative pregnancy test before starting the study drug.

Who may not be able to join:

• People whose tumour has a genetic feature called 1p/19q co-deletion.
• People whose tumour has an IDH mutation, confirmed by laboratory testing.
• People whose tumour is located mainly in the brainstem or spinal cord.
• People whose cancer has spread throughout the fluid around the brain and spinal cord, or has spread outside the brain.
• People who have previously been treated with a type of drug called a PARP inhibitor (such as olaparib or niraparib).
• People who have previously received drugs that target blood vessel growth in tumours (such as bevacizumab or similar medicines).
• People who have previously received certain types of immunotherapy drugs that work on the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-CTLA-4 treatments, including ipilimumab).
• People who have previously received virus-based therapies or vaccines specifically for glioblastoma.
• People who have received certain blood cell-stimulating medications (such as G-CSF or erythropoietin) within 28 days before starting the study.
• People who need ongoing high-dose steroid treatment (specifically more than 2 mg per day of dexamethasone or an equivalent dose) for at least 3 days in a row within 2 weeks of starting the study.
• People who have received certain immune-suppressing medications (other than steroids, such as methotrexate or azathioprine) within the past 6 months.
• People currently taking certain anti-seizure medications that affect how the body processes drugs (called enzyme-inducing anti-epileptic drugs), unless they have stopped taking them at least 14 days before starting the study.
• People currently taking certain medications that strongly affect a liver enzyme called CYP3A, unless they have stopped at least 7 days before starting the study. People must also avoid eating grapefruit, Seville oranges, and similar citrus fruits from 7 days before starting the study and throughout the treatment period.
• People currently taking part in another clinical trial with an investigational drug.
• People currently using certain herbal supplements, including St. John's wort, cannabis, ginkgo biloba, ginseng, or others listed in the trial protocol — these must be stopped at least 7 days before starting the study.
• People currently taking warfarin or similar blood-thinning medications (coumadin-type anticoagulants) — these must be stopped at least 7 days before starting. Certain other blood thinners (low molecular weight heparin and Factor Xa inhibitors) are permitted.
• People with a known allergy to drugs similar in composition to olaparib, temozolomide, or pembrolizumab.
• People with a history of certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia).
• People with a history of significant bleeding within or around their brain tumour, as determined by the treating doctor.
• People with serious uncontrolled health conditions, such as active infections, chronic liver disease, chronic kidney disease, chronic lung disease, or mental health conditions that would make it difficult to follow the study requirements.
• People with an active infection that requires medication given through a drip or injection, or with known infections such as HIV, hepatitis B, or hepatitis C.
• People with a known history of active tuberculosis (TB).
• People with a known immune deficiency condition, including HIV.
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years (hormone replacement therapies are generally not considered systemic treatment in this context — confirm with trial site).
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in the trial.
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, or yellow fever vaccines) within 30 days before starting the study. Note: standard injected flu vaccines are generally allowed, but nasal spray flu vaccines are not.
• People experiencing moderate or severe diarrhoea (Grade 2 or higher on a standard medical scale).
• People with active heart problems, including chest pain requiring medication, certain abnormal heart rhythms, heart valve problems affecting heart function, inflamed heart lining (pericarditis), unstable heart disease, significantly prolonged heart electrical intervals, or certain electrolyte imbalances.
• People with a history of significant heart conditions, including a heart attack within the past 6 months, moderate to severe heart failure, cardiomyopathy, or a congenital heart rhythm condition (confirm specific details with trial site).
• People with digestive system problems that could affect how the body absorbs the study drugs, such as severe nausea, vomiting, uncontrolled diarrhoea, or conditions affecting the bowel.
• People who have had major surgery within 4 weeks before starting the study, or who have not yet recovered from surgery.
• People who are pregnant or currently breastfeeding.
• People with a known bleeding disorder, a history of significant bleeding within the past 12 months, or a serious bleeding event within the past 6 months.
• People with a known history of, or current signs of, non-infectious lung inflammation (pneumonitis).

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