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

Lead Sponsor

Regeneron Pharmaceuticals

Collaborators

Age

0 - 25 years

Sex

ALL

Healthy Volunteers

No

•1. Age 0 to \<18 years of age (Phase 1)
•2. Age ≥3 and ≤25 years of age (Efficacy Phase)
•3. Karnofsky performance status ≥50 (patients \>16 years) or Lansky performance status ≥50 (patients ≤ 16 years)
•4. Life expectancy \>8 weeks
•5. Adequate Bone Marrow Function
•6. Adequate Renal Function
•7. Adequate Liver Function
•8. Adequate Neurologic Function

•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 \>2 lobes
•3. Patients who are receiving any other investigational anticancer agent(s)
•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 in the last 7 days
•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

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