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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07567469
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • High-Grade Glioma (HGG)
  • Posterior Fossa-A Ependymoma

Eligibility Criteria

Sex
ALL
Age
0 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Aug 27, 2032
Completion
Aug 17, 2034

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Arm A
    Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab
  • Experimental: Phase 1 Arm B
    Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab
  • Experimental: Phase 2
    Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab

Primary Outcome Measure

Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 26 months ]

Central Contacts