High-Grade Glioma (HGG)Phase 1/2NCT07567469
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
A Phase 1/2 study testing Cemiplimab and Cemiplimab+Fianlimab Fixed Dose Combination (FDC) in people with High-Grade Glioma (HGG) and Posterior Fossa-A Ependymoma, run by Regeneron Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 39 years
- Conditions the study is for
- High-Grade Glioma (HGG), Posterior Fossa-A Ependymoma
- What is being tested?
- Cemiplimab and Cemiplimab+Fianlimab Fixed Dose Combination (FDC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 17 Aug 2034
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
- Note: Other protocol defined Inclusion/ Exclusion Criteria apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2 Open-Label, Safety and Efficacy Study of Neoadjuvant Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) and Cemiplimab Alone Followed by Adjuvant Fianlimab in Combination With Cemiplimab in Pediatric and Young Adult Participants With Recurrent or Progressive High-Grade Glioma or Pediatric and Adult Participants With Recurrent or Progressive Posterior Fossa-A Ependymoma
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.
Read more
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)
- Being tested
- Cemiplimab, Cemiplimab+Fianlimab Fixed Dose Combination (FDC)
- Keywords
- Recurrent, Progressive, Pediatric Central Nervous System (CNS) tumors, Posterior Fossa A (PF-A), Ependymoma
- Medical subject headings
- Glioma, Recurrence, Neoplasms, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, Libtayo®
Administered per the protocol
Cemiplimab+Fianlimab Fixed Dose Combination (FDC)Drug
Also called REGN 2810, Libtayo®, REGN3767
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Arm A | Experimental | Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab Receives: Drug: Cemiplimab; Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC) |
| Phase 1 Arm B | Experimental | Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab Receives: Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC) |
| Phase 2 | Experimental | Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab Receives: Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 26 months
Severity of TEAEs
Measured: Up to 26 months
Overall Survival (OS)
Measured: 12 months
Progression Free Survival (PFS)
Measured: 12 months
Secondary outcomes (11)
Concentrations of fianlimab in serum
Measured: Up to 5 years
Concentrations of cemiplimab in serum
Measured: Up to 5 years
Occurrence of Anti-Drug Antibody (ADA) to fianlimab
Measured: Up to 5 years
Occurrence of ADA to cemiplimab
Measured: Up to 5 years
Magnitude of ADA to fianlimab
Measured: Up to 5 years
Magnitude of ADA to cemiplimab
Measured: Up to 5 years
Progression Free Survival (PFS)
Measured: Up to 5 years
Death due to any cause
Measured: Up to 5 years
Overall Survival
Measured: Up to 5 years
Occurrence of TEAEs
Measured: Up to 5 years
Severity of TEAEs
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start31 Aug 2026 (estimated)
- Primary completion27 Aug 2032 (estimated)
- Study completion17 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Glioma (HGG)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 will be parallel assignment Phase 2 will be single assignment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567469
- Sponsor's protocol ID
- R3767-ONC-2320
- Other IDs
- 2025-521485-96-00, 2025
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing