Study on PEP-CMV and Nivolumab for Treating Newly Diagnosed and Recurrent High-Grade Brain Tumors in Children and Young Adults

Exclusion Criteria

• Women who are pregnant or breastfeeding cannot participate due to potential risks to the baby. Pregnancy tests are required for girls and women who have started menstruating, at least 7 days before joining the study. Participants who can have children must agree to use effective birth control.
• Active infections that need treatment will disqualify participation.
• Patients with cancer related to HIV or organ transplants, or those with a history of HIV, hepatitis B, or hepatitis C, are not eligible. Testing for these viruses is only needed if there is a clinical reason.
• Patients with diseases that weaken the immune system cannot participate.
• Patients with serious unrelated health issues, such as heart, liver, kidney, or lung problems that require medical treatment or limit daily activities, are not eligible. This includes conditions like COPD, asthma, or having had part of a lung removed.
• Patients taking medications that suppress the immune system for other health conditions cannot participate, except for inhaled steroids for asthma.
• Patients currently receiving other cancer treatments or investigational drugs cannot join the study.
• Patients who have previously participated in an interventional clinical trial (Stratum 1 only) are not eligible.
• Patients taking more than 0.1 mg/kg/day of dexamethasone, up to a maximum of 4 mg/day, cannot participate.
• Patients who cannot attend follow-up visits or complete necessary follow-up tests to monitor treatment side effects are not eligible.
• Patients at high risk of rapid neurological decline due to large tumors, brain shift, or herniation seen on MRI should be discussed with the study leaders before joining.