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:

• Adults aged 18 or older
• People who have either a newly suspected diagnosis of GBM (a type of brain tumour) based on an MRI scan, or a confirmed GBM diagnosis who have not yet received radiation therapy or drug treatment for their brain tumour
• People whose neurosurgeon believes surgery to remove the tumour is needed
• People who are willing to undergo the planned surgical procedures involved in the study
• People who agree to have tissue and other biological samples collected during the study used for research purposes
• People who have already had a biopsy or surgery before enrolling may be eligible if enough stored tissue from that procedure is available; if not enough stored tissue is available, people who are willing to have a repeat biopsy before the study begins may still be eligible (confirm with trial site)
• People whose blood cell counts, clotting function, kidney function, liver function, and protein levels fall within acceptable ranges as measured by blood tests
• People who are generally well and able to carry out daily activities with no or minimal limitations, as assessed by a standard medical scale (ECOG score of 0–1)
• People with a life expectancy of at least 12 months
• People who test negative for HIV, hepatitis B, and hepatitis C at the screening stage (certain follow-up tests may apply — confirm with trial site)
• People who are able to have a brain MRI scan with and without contrast dye
• People who are capable of becoming pregnant must agree to use a highly effective form of contraception during treatment and for at least 6 months after the last dose of study medication, and must agree not to donate eggs during that same period
• People who are capable of producing sperm must use a condom during intercourse and agree not to donate sperm from the time of registration until 3 months after the last dose of treatment
• People capable of becoming pregnant must have a negative pregnancy blood test at screening and within 48 hours before starting the study medication
• People who are able to attend all required study visits and follow the study requirements

Who may not be able to join:

• People whose neurosurgeon does not consider it possible to fully remove the tumour
• People whose tumour is located in the cerebellum, brainstem, or deep basal ganglia (specific areas deep within the brain)
• People who need urgent surgery due to dangerous swelling or pressure in the brain
• People who are unable to have an MRI scan or who are unwilling to undergo MRI
• People who have had a stroke within the 6 months before registering for the trial
• People for whom surgery is medically unsafe
• People currently taking immune-suppressing medications, with the exception of low-dose steroid medication at or below a specific threshold (confirm with trial site)
• People with an active autoimmune disease (where the immune system attacks the body) or immune deficiency condition, including conditions such as lupus, rheumatoid arthritis, multiple sclerosis, or similar diseases
• People with active tuberculosis
• People who have had a confirmed or suspected COVID-19 infection within 4 weeks before screening, or whose symptoms or after-effects from COVID-19 could increase the risk of receiving the trial treatment
• People with active bleeding inside the brain or tumour that requires urgent treatment
• People who have had a serious infection within 4 weeks before registering
• People who have received a live vaccine within 4 weeks before registering, or who expect to need one during the study or within 5 months of the final doses of the study drugs nivolumab and relatlimab
• People currently receiving treatment for another unrelated cancer, with some exceptions for certain past skin cancers or cancers with no signs of disease for 2 or more years (confirm with trial site)
• People who have had a major surgical procedure (other than for diagnosis) within 4 weeks before registering
• People with a history of certain lung conditions, including scarring of the lung tissue or drug-related lung inflammation, or who have signs of active lung inflammation
• People who are pregnant or breastfeeding/chestfeeding
• People who have previously received a stem cell transplant or a donor organ transplant
• People with a known allergy or sensitivity to nivolumab, relatlimab, temozolomide, or any ingredients in these medications
• People with a condition that, in the trial doctor's opinion, would prevent them from giving informed consent or following the study requirements
• People with a history of myocarditis (inflammation of the heart muscle)
• People with elevated heart enzyme (troponin) levels above a certain threshold, depending on follow-up test results and specialist assessment (confirm with trial site)
• People with reduced heart pumping function, specifically a left ventricular ejection fraction below 50%, as measured by a heart scan within the past 6 months
• People with any other significant medical condition that, in the trial doctor's opinion, could pose a safety risk or interfere with the study

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