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 (PNOC013)


Phase I will include children 0 years of age to <18 years of age with recurrent or refractory solid or CNS tumors. Efficacy Phase will include children and young adults ≥3 years of age and <25 years of age with newly diagnosed diffuse intrinsic pontine glioma (DIPG), newly diagnosed high-grade glioma (HGG), or recurrent HGG.

I'm interested

up to 25 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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 Key
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

Drug: cemiplimab (monotherapy), Drug: cemiplimab (maintenance), Radiation: Conventional or hypofractionated, Radiation: Re-irradiation

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

Kris Beatrez -
Christopher Moertel, MD
Phase 1/Phase 2
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