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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 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

DRUG

Cemiplimab

Administered per the protocol

DRUG

Cemiplimab+Fianlimab Fixed Dose Combination (FDC)

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2032-08-27
Completion
2034-08-17
FDA Drug
Yes

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567469 on ClinicalTrials.gov