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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
Phase 1: * To confirm the safety and anticipated recommended phase 2 dose (RP2D) of REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors * To characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or CNS tumors Phase 2 (Efficacy Phase): * To confirm the safety and anticipated RP2D of REGN2810 to be given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) * To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed high-grade glioma (HGG) * To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with re-irradiation in patients with recurrent HGG * To assess PK of REGN2810 in pediatric patients with newly diagnosed DIPG, newly diagnosed HGG, or recurrent HGG when given in combination with radiation * To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at 12 months (OS12) among patients with newly diagnosed DIPG * To assess anti-tumor activity of REGN2810 in combination with radiation in improving progression-free survival at 12 months (PFS12) among patients with newly diagnosed HGG * To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at OS12 among patients with recurrent HGG
Age
0 - 25 years
Sex
ALL
Healthy Volunteers
No
Children's Hospital Los Angeles (CHLA)
Los Angeles, California, United States
Rady Children's Hospital
San Diego, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's National Health System (Children's National Medical Center)
Washington D.C., District of Columbia, United States
University of Florida- Neurosurgery
Gainesville, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins - Pediatric Oncology
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute/ Boston Children's Hospital
Boston, Massachusetts, United States
C. S. Mott/University of Michigan
Ann Arbor, Michigan, United States
Start Date
September 24, 2018
Primary Completion Date
May 10, 2023
Completion Date
May 10, 2023
Last Updated
April 8, 2025
57
ACTUAL participants
cemiplimab (monotherapy)
DRUG
cemiplimab (maintenance)
DRUG
Conventional or hypofractionated
RADIATION
Re-irradiation
RADIATION
Lead Sponsor
Regeneron Pharmaceuticals
Collaborators
NCT03739827
NCT06721689
Data Source & Attribution
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