High-Grade Glioma (HGG), Posterior Fossa-A Ependymoma
Conditions
Keywords
Recurrent, Progressive, Pediatric Central Nervous System (CNS) tumors, Posterior Fossa A (PF-A), Ependymoma
Brief 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)
Interventions
DRUGCemiplimab
Administered per the protocol
DRUGCemiplimab+Fianlimab Fixed Dose Combination (FDC)
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1 will be parallel assignment Phase 2 will be single assignment
Eligibility
Sex/Gender
ALL
Age
0 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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 2. Participant must have histologically confirmed (at initial diagnosis or relapse) HGG or PF-A ependymoma 3. Participant must be an adequate medical candidate for surgical resection as described in the protocol 4. 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 5. Adequate organ function as described in the protocol Key
Exclusion criteria
1. Active autoimmune disease requiring systemic immunosuppressive therapy in the past 2 years 2. Active, serious medical illness, infection or other systemic illness which would limit participation in the trial 3. Has not yet recovered from any acute toxicities resulting from prior therapy 4. History of myocarditis 5. Prior treatment with antibodies to Programmed Cell Death Protein -1 (PD-1), Programmed Cell Death Protein Ligand -1 (PD-L1), Lymphocyte Activation Gene 3 (LAG3), or Cytotoxic T-Lymphocyte Associated protein 4 (CTLA-4) 6. Treatment with high dose systemic corticosteroids as described in the protocol 7. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to 26 months |
| Severity of TEAEs | Up to 26 months |
| Overall Survival (OS) | 12 months |
| Progression Free Survival (PFS) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Concentrations of fianlimab in serum | Up to 5 years |
| Concentrations of cemiplimab in serum | Up to 5 years |
| Occurrence of Anti-Drug Antibody (ADA) to fianlimab | Up to 5 years |
| Occurrence of ADA to cemiplimab | Up to 5 years |
| Magnitude of ADA to fianlimab | Up to 5 years |
| Magnitude of ADA to cemiplimab | Up to 5 years |
| Progression Free Survival (PFS) | Up to 5 years |
| Death due to any cause | Up to 5 years |
| Overall Survival | Up to 5 years |
| Occurrence of TEAEs | Up to 5 years |
| Severity of TEAEs | Up to 5 years |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed