Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03690869 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT03690869 is a Phase 1 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 57 participants.
The verdict
NCT03690869, a Phase 1 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study 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
Interventions
- RADIATION Re-irradiation
- DRUG cemiplimab (monotherapy)
- DRUG cemiplimab (maintenance)
- RADIATION Conventional or hypofractionated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2023-05-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03690869
The ClinicalTrials.gov registry entry for NCT03690869 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Re-irradiation is the first listed.
NCT03690869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03690869 about?
NCT03690869 is a clinical study titled "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". 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 sol...
What is the current status of trial NCT03690869?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2018-09-24. Estimated completion is 2023-05-10.
What interventions are being tested in trial NCT03690869?
The interventions under investigation include: Re-irradiation (RADIATION), cemiplimab (monotherapy) (DRUG), cemiplimab (maintenance) (DRUG), Conventional or hypofractionated (RADIATION).
Who is sponsoring clinical trial NCT03690869?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.