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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521485-96-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Arm A | Experimental | Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab |
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| Phase 1 Arm B | Experimental | Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab |
|
| Phase 2 | Experimental | Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemiplimab | Drug | Administered per the protocol |
|
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion Criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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Phase 1 will be parallel assignment Phase 2 will be single assignment
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| Cemiplimab+Fianlimab Fixed Dose Combination (FDC) | Drug | Administered per the protocol |
|
|
| 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 |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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