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PD-1 Inhibitor

Conventional or hypofractionated for Central Nervous System Tumor

Phase 1 & 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1st follow-up visit, approximately 25 months
Awards & highlights

Study Summary

This trial will take place in two phases. In phase 1, the safety and ideal dosage of the drug will be determined for children with recurrent or difficult-to-treat solid tumors or central nervous system tumors. In phase 2, the drug will be administered to children with newly diagnosed tumors of the brainstem or high-grade tumors elsewhere in the brain, either alone or in combination with radiation therapy, to see if it improves overall survival.

Eligible Conditions
  • Central Nervous System Tumor
  • Diffuse Intrinsic Pontine Glioma
  • Brain Tumor
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1st follow-up visit, approximately 25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1st follow-up visit, approximately 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events of special interest (AESIs)
Incidence and severity of immune-related adverse events (irAEs)
Incidence and severity of serious adverse events (SAEs)
+9 more
Secondary outcome measures
Incidence of anti-drug antibodies (ADA) to REGN2810 given as monotherapy
Incidence of anti-drug antibodies (ADA) to REGN2810 given in combination with radiation
Objective response rate (ORR)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 1Experimental Treatment1 Intervention
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).
Group II: Efficacy with Recurrent HGGExperimental Treatment2 Interventions
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
Group III: Efficacy with Newly Diagnosed HGGExperimental Treatment2 Interventions
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
Group IV: Efficacy with Newly Diagnosed DIPGExperimental Treatment2 Interventions
≥ 3 to < 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
619 Previous Clinical Trials
380,198 Total Patients Enrolled
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
680 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
261 Previous Clinical Trials
251,007 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health benefits does REGN2810 (monotherapy) offer to patients?

"Typically, REGN2810 (monotherapy) is utilized to treat alk gene mutations. Additionally, it can be used for a range of other medical concerns like metastatic cutaneous squamous cell carcinoma and malignant neoplasms."

Answered by AI

Are new participants being sought to participate in this experiment?

"Clinicaltrials.gov confirms that this clinical research is still recruiting participants, with the original posting dating back to October 3rd 2018 and an update edited on January 27th 2022."

Answered by AI

What prior research entailing REGN2810 (monotherapy) has been conducted?

"At present, there are 56 ongoing clinical trials investigating the effectiveness of REGN2810 (monotherapy). Of these studies, 4 have advanced to Phase 3. Barcelona and California boast a number of active research sites for this treatment; however, 1738 other locations are running trials related to REGN2810 (monotherapy) as well."

Answered by AI

How many participants have enrolled in this research endeavor?

"Regeneron Pharmaceuticals is responsible for running this medical trial, which necessitates the recruitment of 130 participants who meet all criteria. The study will be hosted at Children's Hospitals and Clinics of Minnesota in Minneapolis, MN as well as Dana Farber Cancer Institute/ Boston Children's Hospital in Boston, MA."

Answered by AI

How many places in the U.S. are currently conducting this trial?

"Currently, this trial is admitting participants at 19 locations throughout the US. The main cities with these clinical sites are Minneapolis, Boston and Los Angeles; however there are also other centres in various areas where patients can apply to participate. It would be beneficial for individuals to choose a site closest to their residence as that will minimize any necessary travel distances if they join the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2018. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03690869.
~9 spots leftby Apr 2025
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