A Study of the Safety and Preliminary Effectiveness of Pembrolizumab Immunotherapy to Treat Children and Adolescents with Recurrent or Persistent High-Grade Glioma or Diffuse Intrinsic Pontine Glioma

Share

Full Title

A Safety and Preliminary Efficacy trial of Pembrolizumab (MK-3475) 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)

Purpose

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).

Who Can Join

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.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

15-118

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT02359565