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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2025
  • participants needed
    130
  • sponsor
    Regeneron Pharmaceuticals
Updated on 28 October 2020
Investigator
Lindsay B. Kilburn, MD
Primary Contact
Children's National Health System (Children's National Medical Center) (5.4 mi away) Contact
+14 other location
renal function
karnofsky performance status
malignant glioma
recurrent glioma
dipg
cns neoplasm
diffuse intrinsic pontine glioma
central nervous system tumor
re-irradiation
regn2810

Summary

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

Details
Treatment re-irradiation, REGN2810 (monotherapy), REGN2810 (maintenance), Conventional or hypofractionated
Clinical Study IdentifierNCT03690869
SponsorRegeneron Pharmaceuticals
Last Modified on28 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 25 yrs?
Gender: Male or Female
Do you have any of these conditions: Diffuse Intrinsic Pontine Glioma or Relapsed Solid Tumor or High Grade Glioma or Refractory Central Nervous System Tumor or Relapsed Central Nervous S...?
Age 0 to <18 years of age (Phase 1)
Age 3 and 25 years of age (Efficacy Phase)
Karnofsky performance status 50 (patients >16 years) or Lansky performance status 50 (patients 16 years)
Life expectancy >8 weeks
Adequate Bone Marrow Function
Adequate Renal Function
Adequate Liver Function
Adequate Neurologic Function

Exclusion Criteria

Patients with bulky metastatic disease of the CNS causing Uncal herniation or symptomatic midline shift, significant, symptomatic mass effect, or uncontrolled neurological symptoms such as seizures or altered mental status
Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of >2 lobes
Patients who are receiving any other investigational anticancer agent(s)
Patients on greater than dexamethasone 0.1 mg/kg/day (maximum 4 mg/day) or equivalent dose in alternate corticosteroid, or actively undergoing corticosteroid dose escalation in the last 7 days
Patients with a history of allogeneic stem cell transplant
Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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