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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07567469
- Acronym / sponsor ID
- R3767-ONC-2320
- Keywords
- Recurrent, Progressive, Pediatric Central Nervous System (CNS) tumors, Posterior Fossa A (PF-A), Ependymoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 27 Aug 2032 (estimated)
- Study completion
- 17 Aug 2034 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1 will be parallel assignment Phase 2 will be single assignment
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Arm A | Experimental | Drug: Cemiplimab, Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC)Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab |
| Phase 1 Arm B | Experimental | Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC)Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab |
| Phase 2 | Experimental | Drug: Cemiplimab+Fianlimab Fixed Dose Combination (FDC)Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab |
Who may qualify
- Ages
- 0 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: REGN2810, Libtayo®Administered per the protocol | Drug | Phase 1 Arm A |
| Cemiplimab+Fianlimab Fixed Dose Combination (FDC)Also: REGN 2810, Libtayo®, REGN3767Administered per the protocol | Drug | Phase 1 Arm A, Phase 1 Arm B, Phase 2 |
Primary outcome
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 26 months
Severity of TEAEs
Time frame: Up to 26 months
Overall Survival (OS)
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
11 secondary outcomes
Concentrations of fianlimab in serum
Time frame: Up to 5 years
Concentrations of cemiplimab in serum
Time frame: Up to 5 years
Occurrence of Anti-Drug Antibody (ADA) to fianlimab
Time frame: Up to 5 years
Occurrence of ADA to cemiplimab
Time frame: Up to 5 years
Magnitude of ADA to fianlimab
Time frame: Up to 5 years
Magnitude of ADA to cemiplimab
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Death due to any cause
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Occurrence of TEAEs
Time frame: Up to 5 years
Severity of TEAEs
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 26 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.