Protocol Summary

Protocol No.: OCR15952

Sponsor Protocol No.: CA209-908

Study Title
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies

Principal Investigator(s)
Gururangan, Sridharan

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.

Phase: Phase I/II

Age Group: Both

Scope: National

Module A: nivolumab

Module B: nivolumab plus ipilimumab

Detailed Eligibility
1. Ages 6 months to 21 years old
2. Children and adolescents diagnosed with either:
- Diffuse Intrinsic Pontine Glioma (DIPG)
- High Grade Glioma (HGG)
- Medulloblastoma
- Ependymoma
- Other high-grade tumors of the central nervous system
3. Lansky play score (LPS) for = 16 years of age assessed within two weeks of enrollment must be >= 60
4. A tumor sample must be available for submission to central laboratory [not required for DIPG]

1. Participants with active, known or suspected autoimmune disease
2. Participants unable to taper steroids due to ongoing mass effect
3. Participants with low-grade gliomas or tumors of unknown malignant potential
4. Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

** Contact study team for additional eligibility details

Applicable Disease Sites
Brain and Nervous System
Pediatric (Childhood) Cancer

Participating Institutions
UF Gainesville : Jennifer King

Jennifer King, RN, CRC
Phone: +1 352-294-8374