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NCT02359565 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Malignant Glioma and Lynch Syndrome, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
71
Enrollment target
12
Study locations

NCT02359565: Active Phase 1 study of Malignant Glioma and Lynch Syndrome, sponsored by National Cancer Institute (NCI).

NCT02359565 is a Phase 1 study of Malignant Glioma and Lynch Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 71 participants, below the 90-participant average among 40 other Malignant Glioma trials with a reported enrollment target (21% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02359565, a Phase 1 study of Malignant Glioma and Lynch Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
71 participants
Enrollment target
12
Study locations

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.

Primary Outcome

Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events observed during the dose finding period as well as during later courses will be summarized by stratum and by dose (if applicable). Separate tables for adverse events attributable to pembrolizumab will also be provided for each of the five strata.

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Diffusion Weighted Imaging
  • PROCEDURE Conventional Magnetic Resonance Imaging
  • PROCEDURE Diffusion Tensor Imaging
  • PROCEDURE Dynamic Contrast-enhanced MR Perfusion

Study Locations (12)

California

  • Children's Hospital Los Angeles - Los Angeles
  • Lucile Packard Children's Hospital Stanford University - Palo Alto

Colorado

  • Children's Hospital Colorado - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta

Illinois

  • Lurie Children's Hospital-Chicago - Chicago

New York

  • Memorial Sloan Kettering Cancer Center - New York

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Pennsylvania

  • Children's Hospital of Pittsburgh of UPMC - Pittsburgh

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2015-06-03
Est. Completion 2027-01-16
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT02359565 still lists

NCT02359565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 90-participant average among 40 other Malignant Glioma trials with a reported enrollment target (21% lower).

The record links to 10 conditions, with Malignant Glioma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02359565 lists 12 locations in 11 states (California, Colorado, District of Columbia).

Frequently Asked Questions

What is clinical trial NCT02359565 about?

NCT02359565 is a clinical study titled "Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma". 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 tumo...

What is the current status of trial NCT02359565?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2015-06-03. Estimated completion is 2027-01-16.

What conditions does trial NCT02359565 study?

This clinical trial studies the following conditions: Malignant Glioma, Lynch Syndrome, Recurrent Medulloblastoma, Recurrent Brain Neoplasm, Recurrent Diffuse Intrinsic Pontine Glioma.

What interventions are being tested in trial NCT02359565?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Diffusion Weighted Imaging (PROCEDURE), Conventional Magnetic Resonance Imaging (PROCEDURE), Diffusion Tensor Imaging (PROCEDURE), Dynamic Contrast-enhanced MR Perfusion (PROCEDURE).

Who is sponsoring clinical trial NCT02359565?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02359565 being conducted?

This trial has 12 study locations across California, Colorado, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Malignant Glioma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02359565's enrollment target sits among peer trials

71 14th of 40 higher than 27 of 40 other Malignant Glioma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Malignant Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02359565, the US trial registry maintained by the National Library of Medicine. NCT02359565 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.