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

Status: Recruiting
Phase:
DFCI Protocol ID: 18-236

Phase 1: To confirm the safety and anticipated recommended phase 2 dose (RP2D) of the PD-1 inhibitor REGN2810 (cemiplimab) for children with recurrent or refractory solid or CNS tumors and to characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or Central Nervous System (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

Conducting Institutions:

Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:

Susan Chi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Key Inclusion Criteria:

  1. Age 0 to <18 years of age (Phase 1)

  2. Age ≥3 and ≤25 years of age (Efficacy Phase)

  3. Karnofsky ≥50 for patients >16 years of age and Lansky ≥50 for patients ≤ 16 years of
     age

  4. Patients who are receiving corticosteroids must be on a stable or decreasing dose for
     at least 7 days prior to enrollment

  5. Adequate Bone Marrow Function

  6. Adequate Renal Function

  7. Adequate Liver Function

  8. Adequate Neurologic Function

Key Exclusion Criteria:

  1. Patients with bulky, metastatic disease of the CNS causing Uncal herniation or
     symptomatic midline shift, significant, symptomatic mass effect, or uncontrolled
     neurological symptoms such as seizures or altered mental status

  2. Patients with metastatic spine disease and gliomatosis as documented by diffuse
     involvement of greater than 2 lobes

  3. Patients who are receiving any other investigational agents

  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

  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

  7. Prior treatment with idelalisib

Note: Other protocol Inclusion/Exclusion criteria apply

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