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

Study of REGN2810 in Pediatric Patients with Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Study 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

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Diffuse Intrinsic Pontine GliomaGlioma, CNS Tumor, Solid Tumor

Eligibility Overview:

  • Diagnosed with one of the following:
  • Younger than 18 years old (Phase I) or between 3 and 25 years old (Efficacy Phase)
  1. Brief Summary

    This is a safety and efficacy, multi-center study of REGN2810 (cemiplimab), a PD-1 inhibitor monoclonal antibody. This trial is conducted through the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and consists of two phases to be carried out simultaneously in parallel.

    In Phase I, the study will confirm the anticipated recommended Phase II dose of REGN2810 in patients with solid tumors and CNS tumors. The Efficacy Phase will include patients diagnosed with diffuse intrinsic pontine glioma (DIPG), newly diagnosed high-grade glioma (HGG) and recurrent HGG.

    The results of this study will provide insight to optimally guide the development of REGN2810 for DIPG and newly diagnosed and recurrent HGG and in combination with radiation, and potentially as treatment for other pediatric brain tumors.

    Primary Objectives include:

    • To confirm the safety and recommended Phase II dose of REGN2810 for children with recurrent or refractory solid or CNS tumors
    • To confirm the safety and anticipated recommended Phase II dose of REGN2810 when given with conventionally fractionated or hypofractionated radiation in patients with newly diagnosed DIPG, HGG
    • To confirm the safety and anticipated recommended Phase II dose of REGN2810 given with re-irradiation in patients with recurrent HGG

    Eligibility Criteria

    Inclusion criteria include:

    Phase I

    • Diagnosed with one of the following:
      • Recurrent or refractory solid or CNS tumor
      • DIPG
      • Newly diagnosed or recurrent HGG
    • Younger than 18 years old
    • Not pregnant

    Efficacy Phase

    • Between 3 and 25 years old

    Exclusion Criteria include:

    • Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway
    • Metastatic spine disease and gliomatosis
    • Bulky, metastatic disease of the CNS causing uncal herniation or symptomatic midline shift; significant, symptomatic mass effect; or uncontrolled neurological symptoms

    Study Design

    Multicenter, Phase I and early efficacy study. Phase I and Efficacy Phase will be carried out simultaneously.

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating sites in the U.S.

  2. 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.

    You may or may not benefit from taking part in this study. However, this study treatment may help reduce the size of your tumor or improve your quality of life. By taking part in this study, you may help doctors learn more about your cancer, which may help children and adolescents in the future

    Purpose of this clinical trial

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

  3.  PNOC013 Quick View
    Sponsors Regeneron Pharmaceuticals
    ClinicalTrials.gov identifier NCT03690869
    Trial Start Date October 2018
    Estimated Enrollment 150 (10 at St. Jude)
    Study Type: Interventional
    Study Phase Phase I/II
    Conditions Brain tumors
    Ages Up to 25 years old
    Study Sites: St. Jude Children’s Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss PNOC013: St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Amar Gajjar, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org