PNOC019 is a clinical trial for children and young adults with high-grade glioma that has come back or continued to grow after treatment.The study is testing an immunotherapy drug called Nivolumab, which helps the immune system recognise and attack cancer cells. In this study, participants receive nivolumab before surgery (if surgery is planned) and continue treatment afterwards. Researchers will analyse tumour samples and monitor participants closely to understand how the immune system responds to the treatment and whether it can help control the tumour. The goal is to determine whether this approach is safe and whether it can improve outcomes for patients with this aggressive type of brain tumour
PNOC019 is a Phase I/II, single-arm study evaluating neoadjuvant and adjuvant Nivolumab in pediatric and young adult patients with recurrent or progressive high-grade glioma. Patients receive nivolumab prior to surgical resection (where feasible), followed by continued nivolumab post-operatively. The study incorporates correlative analyses to assess immune modulation within the tumour microenvironment and peripheral immune response. Primary objectives include safety, feasibility, and characterisation of immune-related biological effects. Secondary endpoints include progression-free survival (PFS), overall survival (OS), and radiographic response. The study aims to evaluate whether neoadjuvant checkpoint inhibition enhances anti-tumour immune activity and improves clinical outcomes in this patient population.