drugset / Trial / NCT07567469

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

NCT07567469

Phase 1/2 Not yet recruiting 120 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

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)

Timeline

Start
2026-08-31
Primary completion
2032-08-27
Completion
2034-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody
Subject Fianlimab Monoclonal antibody