Phase 1 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 newly diagnosed with a specific type of brain tumour called glioblastoma (or gliosarcoma) located in the upper part of the brain, confirmed by imaging or tissue testing
• People aged 18 or older
• People who are generally well enough to carry out normal daily activities with little to no limitation (as assessed by their doctor using a standard fitness scale)
• People whose doctors and medical team agree are fit and suitable to receive the study treatment before standard cancer treatment begins
• People whose blood tests show their blood cell counts are within acceptable ranges (red blood cells, white blood cells, platelets, and lymphocytes all at adequate levels)
• People whose kidneys are functioning well enough, based on a standard calculation using a blood test result
• People whose liver is functioning well enough, based on blood test results for liver markers
• People with a life expectancy of more than 12 weeks
• People who are willing to follow the trial's contraception requirements
• People who are willing and able to attend scheduled appointments, follow the treatment plan, and complete required tests and procedures
• People who have given written informed consent to participate

Who may not be able to join:

• People whose cancer has spread outside the brain or to the lining of the brain or spinal cord
• People who have already received treatment for glioblastoma beyond a biopsy or a small surgical removal that left some tumour behind
• People who are taking more than 3mg of dexamethasone (a steroid medication) per day, or an equivalent dose of another steroid, at the time of starting the study treatment
• People who have taken antibiotics in the 30 days before starting the study treatment, unless those antibiotics were given as a precaution during surgery
• People who have significant bleeding in or around the tumour, as judged by their treating doctor
• People with an active autoimmune disease (a condition where the immune system attacks the body), except for certain mild skin conditions not requiring systemic treatment, or well-controlled Type 1 diabetes or thyroid disease managed with medication
• People with severe or uncontrolled serious health conditions, such as significant heart, lung, liver, or kidney problems
• People with a known allergy or sensitivity to ipilimumab or any of its ingredients
• People with a history of certain lung conditions, including interstitial lung disease, idiopathic pulmonary fibrosis, or a drug-related lung condition that previously required steroid treatment, or any currently active lung condition of this type
• People who require ongoing treatment with high-dose steroid tablets or other immune-suppressing medications (above a certain dose threshold) within 14 days before starting the study treatment (inhaled or topical steroids, and low-dose adrenal replacement steroids, may be permitted — confirm with trial site)
• People who have taken part in another clinical trial and received an investigational drug within 28 days, or within 5 half-lives of that drug (whichever is longer), before starting this study treatment
• People who have had another cancer diagnosis within the past 5 years, except for certain early-stage cervical changes treated with a cone biopsy, or certain non-melanoma skin lesions that have been adequately treated
• People who test positive for Hepatitis B surface antigen (a marker of active Hepatitis B infection). People who test positive for a different Hepatitis B marker (core antibody) may still be considered if a separate virus DNA test is negative and they agree to monthly monitoring (confirm with trial site)
• People who test positive for Hepatitis C antibodies
• People with a known immune deficiency condition, a history of organ transplant requiring immune-suppressing medication, or a known HIV or AIDS-related illness
• People whose doctor believes participation would not be in their best interest, or whose health or circumstances might interfere with the trial results or their ability to complete the study
• People who are pregnant or breastfeeding

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