PNOC-013: 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

Purpose

This study is being done to test if cemiplimab-rwlc (“study drug”) can reduce the size of your tumor by helping the immune system destroy the tumor. The study is also being done to test the safety of cemiplimab-rwlc in patients.

The main purpose of this study is to determine if cemiplimab-rwlc will prolong how long you live with the disease, without your disease progressing.

Your participation in this study may last up to 3 years.



Procedures

The study drug cemiplimab-rwlc is given by an intravenous (IV) infusion (a slow “drip” of medication injected into the vein over a set period of time, to deliver a constant amount of therapy).

The study drug will be administered by an IV infusion over 30 minutes every 2 weeks will be given for up to 24 months, if you continue to benefit after 12 months.

You will be assigned to receive cemiplimab-rwlc in combination with standard or hypofractionated (larger doses of radiation each day, but over fewer days than standard radiation) radiation therapy. You will be assigned to a treatment group based on randomization, if you consent to participate in this study. This means you will not know what kind of radiation you will receive until after you consent and are randomized to standard or hypo-fractionated radiation therapy.



Eligibility

  • Age 0 to <18 years of age (Phase 1) Age ≥3 and ≤25 years of age (Efficacy Phase) Karnofsky ≥50 for patients >16 years of age and Lansky ≥50 for patients ≤ 16 years of age
  • Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days prior to enrollment
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Adequate Neurologic Function


Contact

For additional study details and eligibility criteria, please contact Jennifer King:

Age

18 and under
18 to 65

Gender

Male
Female

Monetary compensation

Yes

Can be done from home

No

Keywords

Glioma, Pediatric Brain Tumors, Brain tumor - children, Brain Tumor, Brain Tumors

Principal Investigator

Sridharan Gururangan, MD, FRCP

Department

Neurosurgery

Contact Information

jennifer.king@neurosurgery.ufl.edu

(352) 294-8374


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at UFStudies@health.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

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