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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Administered per the protocol
Administered per the protocol
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 26 months
Severity of TEAEs
Time frame: Up to 26 months
Overall Survival (OS)
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
Concentrations of fianlimab in serum
Time frame: Up to 5 years
Concentrations of cemiplimab in serum
Time frame: Up to 5 years
Occurrence of Anti-Drug Antibody (ADA) to fianlimab
Time frame: Up to 5 years
Occurrence of ADA to cemiplimab
Time frame: Up to 5 years
Magnitude of ADA to fianlimab
Time frame: Up to 5 years
Magnitude of ADA to cemiplimab
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Death due to any cause
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Occurrence of TEAEs
Time frame: Up to 5 years
Severity of TEAEs
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.