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
Conditions:	Brain Cancer, Brain Cancer, Brain Cancer, Neurology
Therapuetic Areas:	Neurology, Oncology
Healthy:	No
Age Range:	Any - 25
Updated:	4/5/2019
Start Date:	October 2, 2018
End Date:	October 2, 2024
Contact:	Clinical Trials Administrator
Email:	clinicaltrials@regeneron.com
Phone:	844-734-6643

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

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

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

We found this trial at

sites

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota 55404

from

Minneapolis, MN