Summary

for people ages up to 25 years (full criteria)
at UCSF
study started
estimated completion

Description

Summary

Phase 1: To confirm the safety and anticipated recommended phase 2 dose (RP2D) of the PD-1 inhibitor REGN2810 (cemiplimab) for children with recurrent or refractory solid or CNS tumors and to characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or Central Nervous System (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

Official Title

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

Keywords

Relapsed Solid Tumor Refractory Solid Tumor Relapsed Central Nervous System Tumor Refractory Central Nervous System Tumor Diffuse Intrinsic Pontine Glioma High Grade Glioma Newly Diagnosed Recurrent Refractory Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms Cemiplimab REGN2810 (monotherapy) REGN2810 (maintenance) Re-irradiation

Eligibility

For people ages up to 25 years

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  1. 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
  2. Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of greater than 2 lobes
  3. Patients who are receiving any other investigational agents
  4. 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
  5. Patients with a history of allogeneic stem cell transplant
  6. Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway
  7. Prior treatment with idelalisib

Note: Other protocol Inclusion/Exclusion criteria apply

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    San Francisco California 94158 United States
  • Rady Children's Hospital accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT03690869
Phase
Phase 1/2
Study Type
Interventional
Last Updated