Experimental drug cocktail takes on childhood brain cancers
NCT ID NCT07567469
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests two immunotherapy drugs, fianlimab and cemiplimab, in children and young adults with recurrent high-grade glioma or ependymoma. The goal is to see if the combination is safe and can shrink tumors or slow their growth. Participants will receive the drugs before and after surgery to remove their tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fianlimab and cemiplimab (immunotherapy drugs)
- What this could lead to
- If successful, this could offer a new treatment option for children and young adults with recurrent brain tumors that are hard to treat.
- What could go wrong
- This is an early-phase trial (phase 1/2) with a small number of participants. The drugs may cause side effects or not work for everyone. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 39 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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/ Exclusion Criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.