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)
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
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
Parallel
Cemiplimab
DrugAdministered per the protocol
Cemiplimab+Fianlimab Fixed Dose Combination (FDC)
DrugAdministered per the protocol
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Severity of TEAEs
Overall Survival (OS)
Progression Free Survival (PFS)
Concentrations of fianlimab in serum
Concentrations of cemiplimab in serum
Occurrence of Anti-Drug Antibody (ADA) to fianlimab
Occurrence of ADA to cemiplimab
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
