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 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: R3767-ONC-23202025-521485-96-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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)

Conditions

High-Grade Glioma (HGG); Posterior Fossa-A Ependymoma

Keywords

Recurrent; Progressive; Pediatric Central Nervous System (CNS) tumors; Posterior Fossa A (PF-A); Ependymoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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

Study Arms (3)

Phase 1 Arm A

EXPERIMENTAL

Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab

Drug: Cemiplimab; Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC)

Phase 1 Arm B

EXPERIMENTAL

Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab

Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC)

Phase 2

EXPERIMENTAL

Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab

Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC)

Interventions

Cemiplimab DRUG

Administered per the protocol

Also known as: REGN2810, Libtayo®

Phase 1 Arm A

Cemiplimab+Fianlimab Fixed Dose Combination (FDC) DRUG

Administered per the protocol

Also known as: REGN 2810, Libtayo®, REGN3767

Phase 1 Arm A; Phase 1 Arm B; Phase 2

Eligibility Criteria

• Age: 0 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Adequate organ function as described in the protocol

You may not qualify if:

• 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
• 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)
• Treatment with high dose systemic corticosteroids as described in the protocol
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Glioma; Recurrence; Neoplasms; Ependymoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 will be parallel assignment Phase 2 will be single assignment

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 27, 2032
• Study Completion (Estimated): August 17, 2034
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: 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