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Protocol # 18-236

Status

Recruiting

Description

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

Condition

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

Interventions

  • cemiplimab (monotherapy)
  • cemiplimab (maintenance)
  • Conventional or hypofractionated
  • Re-irradiation

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence and severity of treatment-emergent adverse events (TEAEs)
  • Incidence and severity of immune-related adverse events (irAEs)
  • Incidence and severity of adverse events of special interest (AESIs)
  • Incidence and severity of serious adverse events (SAEs)
  • Incidence of deaths
  • Incidence of laboratory abnormalities
  • Incidence of dose limiting toxicities (DLTs)
  • Incidence of dose limiting toxicities (DLTs)
  • PK for REGN2810 estimated Observed terminal half-life (t1/2)
  • PK for REGN2810 Concentration at end of infusion (Ceoi)
  • PK for REGN2810 Area under the curve (AUC2w)
  • Overall survival among newly diagnosed DIPG and recurrent HGG patients
  • Progression-free survival among newly diagnosed HGG patients

Secondary Outcome:

  • Objective response rate (ORR)
  • Incidence of anti-drug antibodies (ADA) to REGN2810 given as monotherapy
  • Incidence of anti-drug antibodies (ADA) to REGN2810 given in combination with radiation

Enrollment

130

Study Start Date

October 3, 2018

Eligibility

  • Gender:     All
  • Minimum age:     N/A
  • Maximum age:     25 Years
  • Healthy volunteers:     No

Sponsors

Regeneron Pharmaceuticals

Source

Regeneron Pharmaceuticals

Official title

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

Clinicaltrials.gov Identifier

NCT03690869

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.