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PNOC013: Study of REGN2810 Immunotherapy in Children with Relapsed or Refractory Solid or CNS Tumors and Study of REGN2810 combined with radiation in Children with Newly Diagnosed or Recurrent Glioma

About this study

This clinical trial will test a drug called REGN2810 in children and young adults with solid tumors, CNS tumors and gliomas. REGN2810 is considered an investigational drug because it is not approved by the U.S. Food and Drug Administration.

REGN2810 is a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that help fight infections. A monoclonal antibody is a special antibody created in a laboratory. It binds to specific proteins in the body that may be involved in your cancer. REGN2810 binds to a type of protein called PD-1. This protein limits the immune system’s ability to protect the body from infection and disease. REGN2810 works by blocking PD-1.

This study will be done in two parts: Phase I and Efficacy. Phase I will determine the maximum tolerated dose of REGN2810 that can be given. The Efficacy part of the study will determine if REGN2810 is safe and effective.

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Overview

Full title:

A Safety and Pharmacokinetic Study of Single Agent REGN2810 in Pediatric Patients With Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Trial of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Newly Diagnosed High-Grade Glioma, or Recurrent High-Grade Glioma

Study goal:

The main goal of this study is to find out if REGN2810 works and how safe it is.

Diagnosis:

Diffuse intrinsic pontine glioma, glioma, CNS tumor, solid tumor

Age:

Younger than 18 years old (Phase I) or between 3 and 25 years old (Efficacy Phase)

Clinical trials categories:

Solid Tumors Childhood Cancer Diffuse Intrinsic Pontine Glioma (DIPG) High-Grade Glioma Brain Tumors

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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