Last updated on November 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diffuse Intrinsic Pontine Glioma | Relapsed Solid Tumor | Refractory Solid Tumor | Refractory Central Nervous System Tumor | High Grade Glioma | Relapsed Central Nervous System Tumor
  • Age: - 25 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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