A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-39
SponsorRegeneron Pharmaceuticals

About this trial

This study is researching an experimental drug called cemiplimab (called "study drug") and the combination of experimental drugs of fianlimab and cemiplimab (called "study drugs"). The study is focused on children and young adults with recurrent or progressive High-Grade Glioma (HGG) or ependymoma. "Recurrent" means that the cancer came back after treatment. "Progressive" means that the tumor has grown or spread.

The aim of the study is to see how safe, tolerable, and effective cemiplimab and the combination of fianlimab and cemiplimab are.

The study is looking at several other research questions, including:

* What side effects may happen from receiving the study drug(s) * Do the study drug(s) help study participants live longer without their tumors growing or spreading * How much of the study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug\[s\] less effective or lead to side effects)

Eligibility criteria

Qualifiers

Participant must be diagnosed with recurrent/progressive HGG or PF-A ependymoma with unequivocal progression on Magnetic Resonance Imaging (MRI) as described in the protocol

Participant must have histologically confirmed (at initial diagnosis or relapse) HGG or PF-A ependymoma

Participant must be an adequate medical candidate for surgical resection as described in the protocol

Karnofsky Performance Status (KPS) score ≥50 (in participants ≥16 years) or Lansky Performance Status (LPS) score ≥50 (in participants <16 years) as described in the protocol

Disqualifiers

Active autoimmune disease requiring systemic immunosuppressive therapy in the past 2 years

Active, serious medical illness, infection or other systemic illness which would limit participation in the trial

Has not yet recovered from any acute toxicities resulting from prior therapy

History of myocarditis

Trial design

Treatments tested in this trial

  • Cemiplimab
  • Cemiplimab+Fianlimab Fixed Dose Combination (FDC)

Treatment groups

120 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators