Why are we doing this research?
The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.
PRIMARY OUTCOME MEASURES:
- Incidence of dose limiting toxicity (DLT) [ Time Frame: Approximately 6 weeks ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 6 weeks ]
- Incidence of adverse events (AEs) [ Time Frame: Approximately 6 weeks ]
- Overall Survival (OS) [ Time Frame: Approximately 3 years ]
- Diffuse Intrinsic Pontine Glioma (DIPG).
- Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
Study Type: Interventional
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Who can participate?
AGES ELIGIBLE FOR STUDY: 6 months to 21 Years
- Children and adolescents diagnosed with either:
- Diffuse Intrinsic Pontine Glioma (DIPG), in first-line, after completion of standard radiotherapy
- High Grade Glioma (HGG), recurrent or progressive
- Medulloblastoma, recurrent or progressive
- Ependymoma, recurrent or progressive
- Other high-grade tumors of the central nervous system, recurrent or progressive
- Lansky play score (LPS) for =< 16 years of age or Karnofsky performance scale (KPS) for > 16 years of age assessed within two weeks of enrollment must be >= 60
- A tumor sample must be available for submission to central laboratory [not required for DIPG]
- Participants with active, known or suspected autoimmune disease
- Participants unable to taper steroids due to ongoing mass effect
- Participants with low-grade gliomas or tumors of unknown malignant potential
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
- Other protocol defined inclusion/exclusion criteria could apply