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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат Cemiplimab
  Administered per the protocol
• Препарат Cemiplimab+Fianlimab Fixed Dose Combination (FDC)
  Administered per the protocol

Первичные конечные точки

• Occurrence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 26 months]
• Severity of TEAEs [Срок оценки: Up to 26 months]
• Overall Survival (OS) [Срок оценки: 12 months]
• Progression Free Survival (PFS) [Срок оценки: 12 months]

Вторичные конечные точки (11)

• Concentrations of fianlimab in serum [Срок оценки: Up to 5 years]
• Concentrations of cemiplimab in serum [Срок оценки: Up to 5 years]
• Occurrence of Anti-Drug Antibody (ADA) to fianlimab [Срок оценки: Up to 5 years]
• Occurrence of ADA to cemiplimab [Срок оценки: Up to 5 years]
• Magnitude of ADA to fianlimab [Срок оценки: Up to 5 years]
• Magnitude of ADA to cemiplimab [Срок оценки: Up to 5 years]
• Progression Free Survival (PFS) [Срок оценки: Up to 5 years]
• Death due to any cause [Срок оценки: Up to 5 years]
• Overall Survival [Срок оценки: Up to 5 years]
• Occurrence of TEAEs [Срок оценки: Up to 5 years]
• Severity of TEAEs [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07567469 · R3767-ONC-2320 · 2025-521485-96-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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