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
NCT ID: NCT03690869
Last Updated: 2025-04-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2018-09-24
2023-05-10
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1
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).
cemiplimab (monotherapy)
To be administered intravenously as monotherapy in Phase 1
Efficacy with Newly Diagnosed DIPG
≥ 3 to \< 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
cemiplimab (maintenance)
To be administered intravenously in combination with radiation and then used as maintenance therapy
Conventional or hypofractionated
Combined with cemiplimab IV administration
Efficacy with Newly Diagnosed HGG
≥ 3 to \< 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
cemiplimab (maintenance)
To be administered intravenously in combination with radiation and then used as maintenance therapy
Conventional or hypofractionated
Combined with cemiplimab IV administration
Efficacy with Recurrent HGG
≥ 3 to \< 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
cemiplimab (maintenance)
To be administered intravenously in combination with radiation and then used as maintenance therapy
Re-irradiation
Combined with cemiplimab IV administration
Interventions
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cemiplimab (monotherapy)
To be administered intravenously as monotherapy in Phase 1
cemiplimab (maintenance)
To be administered intravenously in combination with radiation and then used as maintenance therapy
Conventional or hypofractionated
Combined with cemiplimab IV administration
Re-irradiation
Combined with cemiplimab IV administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥3 and ≤25 years of age (Efficacy Phase)
3. Karnofsky performance status ≥50 (patients \>16 years) or Lansky performance status ≥50 (patients ≤ 16 years)
4. Life expectancy \>8 weeks
5. Adequate Bone Marrow Function
6. Adequate Renal Function
7. Adequate Liver Function
8. Adequate Neurologic Function
Exclusion Criteria
2. Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of \>2 lobes
3. Patients who are receiving any other investigational anticancer agent(s)
4. Patients on greater than dexamethasone 0.1 mg/kg/day (maximum 4 mg/day) or equivalent dose in alternate corticosteroid, or actively undergoing corticosteroid dose escalation in the last 7 days
5. Patients with a history of allogeneic stem cell transplant
6. Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway
25 Years
ALL
No
Sponsors
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Pacific Pediatric Neuro-Oncology Consortium
OTHER
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Children's Hospital Los Angeles (CHLA)
Los Angeles, California, United States
Rady Children's Hospital
San Diego, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's National Health System (Children's National Medical Center)
Washington D.C., District of Columbia, United States
University of Florida- Neurosurgery
Gainesville, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins - Pediatric Oncology
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute/ Boston Children's Hospital
Boston, Massachusetts, United States
C. S. Mott/University of Michigan
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota / Masonic Cancer Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University (OHSU) - Doernbecher Children's Hospital
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Texas Children's Cancer & Hematology Centers Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Summary is available on TrialSummaries.com
Other Identifiers
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PNOC 013 (CC#160825)
Identifier Type: OTHER
Identifier Source: secondary_id
R2810-ONC-1690
Identifier Type: -
Identifier Source: org_study_id
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