Protocol Summary

Protocol No.: OCR17419

Sponsor Protocol No.: PNOC 013; R2810-ONC-1690

Protocol Title.: 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

Principal Investigator: Sayour, Elias

Objective: 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

Phase: Phase I/II

Age Group: Both

Age: N/A - 25 Years

Gender: All

Scope: National

Treatment:

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).

Experimental: Efficacy with Newly Diagnosed DIPG
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy

Experimental: Efficacy with Newly Diagnosed HGG
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy

Experimental: Efficacy with Recurrent HGG
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy

Detailed Eligibility:

Key Inclusion Criteria: 1. Age 0 to 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 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 >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

Applicable Conditions:

  • Brain and Nervous System
  • Pediatric (Childhood) Cancer
  • Participation Institution:

  • UF Gainesville : Jennifer King
  • Contact:
    Jennifer King
    Phone: +1 352-294-8374
    Email: Jennifer.King@neurosurgery.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03690869