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
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.
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.
- 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
For additional study details and eligibility criteria, please contact Jennifer King:
- (352) 294-8374
Can be done from home
KeywordsGlioma, Pediatric Brain Tumors, Brain tumor - children, Brain Tumor, Brain Tumors
Principal InvestigatorSridharan Gururangan, MD, FRCP
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