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 are at least 18 years old.
• People who have been diagnosed with a specific type of brain tumour called recurrent or progressive glioblastoma (WHO Grade IV, IDH wild-type) or a related tumour called astrocytoma (WHO Grade IV) that has come back or continued to grow.
• People whose brain scans (MRI) show clear signs that the tumour has grown back or progressed, according to standard medical guidelines called RANO criteria.
• People who have had a contrast-enhanced brain MRI performed within 28 days before joining the study.
• People who finished radiation therapy at least 12 weeks before joining the study — or, if it has been between 4 and 12 weeks since radiation, people whose scans (including specialised imaging such as perfusion MRI or PET scan) clearly show true tumour regrowth rather than a radiation-related effect.
• People whose general physical functioning meets a minimum level, measured by a standard scale called the Karnofsky Performance Status (KPS), with a score of 60% or higher.
• People whose tumour size, location, and shape make them a suitable candidate for a procedure called Magnetic Resonance-guided Laser Ablation (MLA), as judged by the neurosurgeon performing the procedure.
• People who are considered suitable candidates for a device-based treatment called Optune GIO®.
• People who are considered suitable candidates for a drug called pembrolizumab.
• People whose blood and organ function test results meet the required levels — including white blood cell counts, platelets, haemoglobin, kidney function, liver function, and related markers (confirm specific values with the trial site).
• People of childbearing potential who agree to use highly effective contraception throughout the study and for at least 24 weeks after the last dose of study treatment.
• Male participants with female partners who could become pregnant, who agree to use doctor-approved contraception throughout the study and for 24 weeks after the last dose of study treatment.
• People who are able to understand the study information and are willing to sign a formal consent form.

Who may not be able to join:

• People who have previously been treated with anti-blood-vessel-growth (anti-angiogenic) drugs, including a drug called bevacizumab (with a limited exception for a specific radiation-related treatment protocol — confirm with trial site).
• People who have previously received certain immunotherapy drugs that target specific immune system pathways, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (such as ipilimumab).
• People who received a monoclonal antibody treatment within 4 weeks before the planned first dose of pembrolizumab, or who have not yet recovered from side effects of such treatment.
• People who received chemotherapy, targeted drug therapy, or radiation therapy within 2 weeks before the planned first dose of pembrolizumab, or who have not yet recovered from side effects (note: people with mild-to-moderate nerve-related side effects may still be eligible — confirm with trial site).
• People whose tumour is located in certain sensitive brain areas, including the lower back part of the brain (infratentorial region), the brainstem, or within 5mm of the pituitary gland or cranial nerves.
• People with tumours that have spread to both sides of the brain (bilateral multifocal glioma), unless the tumour crosses through a specific brain structure called the corpus callosum and meets the size and shape requirements for MLA — or unless all affected areas can be safely treated in a single MLA procedure (confirm with trial site).
• People who have cancer spread to the lining of the brain or spinal cord beyond the brain cavity (leptomeningeal metastases), with limited exceptions at the investigator's discretion.
• People who require a steroid medication (such as dexamethasone) at a daily dose greater than 4mg.
• People who have had bleeding in the brain within the past 8 weeks, unless the bleeding is within the tumour itself and will be fully removed or treated during the procedure.
• People who need ongoing blood-thinning (anticoagulant) medication at treatment doses, unless it can be safely stopped or an alternative approach (such as a filter placed in a large vein) can be used instead.
• People who have previously had certain local brain treatments — such as stereotactic radiosurgery, internal radiation (brachytherapy), or chemotherapy wafers (carmustine wafers) — in the same area of the brain planned for MLA treatment.
• People who received a live vaccine within 30 days before the planned start of study treatment.
• People who are currently in another clinical trial or who have used an experimental treatment or device within 3 weeks before the planned start of study treatment.
• People who have a condition that weakens the immune system, or who are receiving immune-suppressing therapy within 7 days before the first dose of trial treatment (with the exception of low-dose dexamethasone of 4mg or less per day).
• People with uncontrolled serious health conditions, such as active infection, heart failure, unstable chest pain, irregular heartbeat, uncontrolled high blood pressure, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People who have had an active autoimmune disease requiring systemic medical treatment within the past 2 years (note: certain mild prior autoimmune conditions linked to previous immunotherapy may still be eligible — confirm with trial site).
• People who have had lung inflammation (pneumonitis) not caused by infection within the past 3 years that required steroid treatment, or who currently have pneumonitis (note: certain resolved cases may still be eligible — confirm with trial site).
• People who are pregnant or breastfeeding, or who do not have a negative pregnancy test result within 72 hours of joining the study.
• People with a known active hepatitis B or hepatitis C infection.
• People with a known history of active tuberculosis (TB).
• People with a known history of HIV infection.

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