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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03690869
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • High Grade Glioma
  • Refractory Central Nervous System Tumor
  • Refractory Solid Tumor
  • Relapsed Central Nervous System Tumor
  • Relapsed Solid Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • cemiplimab (monotherapy) — DRUG
    To be administered intravenously as monotherapy in Phase 1
  • cemiplimab (maintenance) — DRUG
    To be administered intravenously in combination with radiation and then used as maintenance therapy
  • Conventional or hypofractionated — RADIATION
    Combined with cemiplimab IV administration
  • Re-irradiation — RADIATION
    Combined with cemiplimab IV administration

Study Details

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

Key Dates

Start date
Sep 24, 2018
Status verified
Apr 2025
Primary completion
May 10, 2023
Completion
May 10, 2023

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Experimental: Efficacy with Newly Diagnosed DIPG
    ≥ 3 to \< 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
  • Experimental: Efficacy with Newly Diagnosed HGG
    ≥ 3 to \< 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy
  • Experimental: Efficacy with Recurrent HGG
    ≥ 3 to \< 12 years cohort and 12 to ≤ 25 years cohort with combination of cemiplimab and radiation therapy

Primary Outcome Measure

Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Children's Hospital Los Angeles (CHLA)Los AngelesCalifornia90054-
Rady Children's HospitalSan DiegoCalifornia92123-
UCSF Benioff Children's HospitalSan FranciscoCalifornia94158-
Children's National Health System (Children's National Medical Center)Washington D.C.District of Columbia20010-
University of Florida- NeurosurgeryGainesvilleFlorida32610-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Johns Hopkins - Pediatric OncologyBaltimoreMaryland21287-
Dana Farber Cancer Institute/ Boston Children's HospitalBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
C. S. Mott/University of MichiganAnn ArborMichigan48109-
Children's Hospitals and Clinics of MinnesotaMinneapolisMinnesota55404-
University of Minnesota / Masonic Cancer CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Nationwide Children's HospitalColumbusOhio43205-
Oregon Health & Science University (OHSU) - Doernbecher Children's HospitalPortlandOregon97239-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. Jude Children's Research HospitalMemphisTennessee38105-
Texas Children's Cancer & Hematology Centers Baylor College of MedicineHoustonTexas77030-
University of UtahSalt Lake CityUtah84113-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles (CHLA)· Los Angeles, CARady Children's Hospital· San Diego, CAUCSF Benioff Children's Hospital· San Francisco, CAChildren's National Health System (Children's National Medical Center)· Washington D.C., DCUniversity of Florida- Neurosurgery· Gainesville, FLAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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