Protocol Summary

Protocol No.: OCR15952

Sponsor Protocol No.: CA209-908

Protocol Title: An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies

Principal Investigator: Gururangan, Sridharan

Objective: 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

Age: 6 Months - 21 Years

Gender: All

Scope: National

Treatment:
Module A: nivolumab
Module B: nivolumab plus ipilimumab

Detailed Eligibility:
INCLUSION CRITERIA:
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]
EXCLUSION CRITERIA:
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 Conditions:

  • Brain and Nervous System
  • Pediatric (Childhood) Cancer
  • Participation Institution:

  • UF Gainesville : Jennifer King
  • Contact:
    Jennifer King, RN, CRC
    Phone: +1 352-294-8374
    Email: Jennifer.King@neurosurgery.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03130959