REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma
Stopped early · Phase 1/Phase 2
Conditions studied: Relapsed Solid Tumor, Refractory Solid Tumor, Relapsed Central Nervous System Tumor, Refractory Central Nervous System Tumor, Diffuse Intrinsic Pontine Glioma, High Grade Glioma
In brief
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
Key facts
- Study ID
- NCT03690869
- Run by
- Regeneron Pharmaceuticals
- People needed
- 57
- Starts
- 2018-09-24
- Expected to finish
- 2023-05-10
- Last updated by the study team
- 2025-04-08
Who can join
Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
- University of Minnesota / Masonic Cancer Center — Minneapolis, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Oregon Health & Science University (OHSU) - Doernbecher Children's Hospital — Portland, Oregon, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Texas Children's Cancer & Hematology Centers Baylor College of Medicine — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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