Stopped: Sponsor Decision
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
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Treatment-emergent Adverse Events (TEAEs)
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs)
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Treatment-emergent AEs of Special Interest (AESI)
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of NCI Grade 3/4/5 Treatment-emergent AESI
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Participants With Any TEAE Resulting in Death
Timeframe: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
Timeframe: Up to 36 months
Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1)
Timeframe: Baseline to 28 days
Number of Participants Who Developed DLTs (Efficacy Phase)
Timeframe: Up to 4 weeks post radiation therapy
Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum
Timeframe: Up to 24 months
Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum
Timeframe: Up to Week 16
Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum
Timeframe: Up to Week 16
Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum
Timeframe: Up to 24 months
Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG)
Timeframe: At 12 months
Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG)
Timeframe: Up to 12 months