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Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma

NCT02359565 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of pembrolizumab and to see how well it works in treating younger patients with high-grade gliomas (brain tumors that are generally expected to be fast growing and aggressive), diffuse intrinsic pontine gliomas (brain stem tumors), brain tumors with a high number of genetic mutations, ependymoma or medulloblastoma that have come back (recurrent), progressed, or have not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system, and may interfere with the ability of tumor cells to grow and spread.

Conditions

  • Constitutional Mismatch Repair Deficiency Syndrome
  • Lynch Syndrome
  • Malignant Glioma
  • Recurrent Brain Neoplasm
  • Recurrent Childhood Ependymoma
  • Recurrent Diffuse Intrinsic Pontine Glioma
  • Recurrent Medulloblastoma
  • Refractory Brain Neoplasm
  • Refractory Diffuse Intrinsic Pontine Glioma
  • Refractory Ependymoma
  • Refractory Medulloblastoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo CSF and blood sample collection

PROCEDURE

Conventional Magnetic Resonance Imaging

Undergo standard MRI

PROCEDURE

Diffusion Tensor Imaging

Undergo DTI

PROCEDURE

Diffusion Weighted Imaging

Undergo MR diffusion imaging

PROCEDURE

Dynamic Contrast-enhanced MR Perfusion

Undergo DCE permeability MRI

PROCEDURE

Dynamic Susceptibility Contrast-Perfusion-Weighted Imaging

Undergo DSC perfusion MRI

PROCEDURE

Magnetic Resonance Spectroscopic Imaging

Undergo MR spectroscopy

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Eugene I Hwang · Pediatric Brain Tumor Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2026-01-05
Completion
2027-01-16
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02359565 on ClinicalTrials.gov