Full TitleA Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory diffuse intrinsic pontine glioma (DIPG), non-brainstem high-grade gliomas (NB-HGG), ependymoma, medulloblastoma or hypermutated brain tumors (PBTC 045)
The purpose of this study is to evaluate the safety and effectiveness of the immunotherapy drug pembrolizumab in children and adolescents with high-grade glioma or diffuse intrinsic pontine glioma that has come back or continued to grow despite therapy.
Pembrolizumab is already approved to treat several cancers in adults; its use in this study is considered investigational. It works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 may allow the immune system to detect and attack glioma cells. Pembrolizumab is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be under age 18 for the safety part of the study, while patients up through age 21 can be in the second part of the study assessing effectiveness.
- Patients must have high-grade glioma or diffuse intrinsic pontine glioma that has come back or continued to grow despite prior radiation therapy and chemotherapy.
- Patients should recover from the serious side effects of prior therapies before entering the study.