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

High Grade Glioma Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03690869
Study type	Interventional
Source	Regeneron Pharmaceuticals
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	September 24, 2018
Completion date	May 10, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05023551` - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma	Early Phase 1
Terminated	`NCT01902771` - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors	Phase 1
Active, not recruiting	`NCT02655601` - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001	Phase 2
Completed	`NCT01466686` - Low Dose Radiation Therapy for Glioblastoma Multiforme	Phase 2
Recruiting	`NCT05212272` - MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Recruiting	`NCT05925218` - Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Active, not recruiting	`NCT04911621` - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma	Phase 1/Phase 2
Not yet recruiting	`NCT06333899` - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion	Early Phase 1
Recruiting	`NCT04734444` - SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue	N/A
Completed	`NCT03775369` - Glioma and Exercising	N/A
Completed	`NCT02022644` - Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma	Phase 1
Completed	`NCT00780819` - Borderzone Sampling	N/A
Recruiting	`NCT06072586` - Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions	Early Phase 1
Completed	`NCT01390948` - A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma	Phase 2
Recruiting	`NCT03952598` - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy	N/A
Recruiting	`NCT05630664` - Liquid Biopsy in High-grade Gliomas and Meningiomas
Recruiting	`NCT05298995` - GD2-CAR T Cells for Pediatric Brain Tumours	Phase 1
Completed	`NCT01222754` - Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas	Phase 1
Recruiting	`NCT05278208` - Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors	Phase 1/Phase 2
Completed	`NCT03355794` - A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)	Phase 1