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
← catalyst calendarNCT07567469 · readout in 2,200 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
120estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-31 | estimated | When the study began enrolling |
| Primary completion | 2032-08-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2034-08-17 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- High-Grade Glioma (HGG)
- Posterior Fossa-A Ependymoma
Interventions
- Drug: Cemiplimab — also filed as REGN2810, Libtayo®
- Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC) — also filed as REGN 2810, Libtayo®, REGN3767
Primary outcomes
what the primary-completion date above is the date OFOccurrence of Treatment Emergent Adverse Events (TEAEs)
measured Up to 26 months
Severity of TEAEs
measured Up to 26 months
Overall Survival (OS)
measured 12 months
Progression Free Survival (PFS)
measured 12 months
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