Children's National

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

Purpose

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

Conditions

Relapsed Solid Tumor
Refractory Solid Tumor
Relapsed Central Nervous System Tumor
Refractory Central Nervous System Tumor
Diffuse Intrinsic Pontine Glioma
High Grade Glioma

Eligibility

Eligible Ages: Under 25 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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 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 Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Phase 1	Patients in both the Solid Tumor Cohort and the CNS Cohort will receive cemiplimab monotherapy. Each Cohort will have 2 subgroups by age (0 to <12 years, 12 to <18 years).	Drug: cemiplimab (monotherapy) To be administered intravenously as monotherapy in Phase 1 Other names: REGN2810 Libtayo
Experimental Efficacy with Newly Diagnosed DIPG	≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy	Drug: cemiplimab (maintenance) To be administered intravenously in combination with radiation and then used as maintenance therapy Other names: REGN2810 Libtayo Radiation: Conventional or hypofractionated Combined with cemiplimab IV administration
Experimental Efficacy with Newly Diagnosed HGG	≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy	Drug: cemiplimab (maintenance) To be administered intravenously in combination with radiation and then used as maintenance therapy Other names: REGN2810 Libtayo Radiation: Conventional or hypofractionated Combined with cemiplimab IV administration
Experimental Efficacy with Recurrent HGG	≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy	Drug: cemiplimab (maintenance) To be administered intravenously in combination with radiation and then used as maintenance therapy Other names: REGN2810 Libtayo Radiation: Re-irradiation Combined with cemiplimab IV administration

Recruiting Locations

More Details

NCT ID: NCT03690869
Status: Terminated
Sponsor: Regeneron Pharmaceuticals

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.