CA209908: Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies

Why are we doing this research?

PURPOSE:

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 ]
    • Safety and tolerability
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 6 weeks ]
    • Safety and tolerability
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 6 weeks ]
    • Safety and tolerability
  • Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    • Diffuse Intrinsic Pontine Glioma (DIPG).
  • Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
    • All other tumor types

Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment

Masking: None

Primary Purpose: Treatment

Who can participate?

AGES ELIGIBLE FOR STUDY: 6 months to 21 Years

ELIGIBILITY CRITERIA

Inclusion Criteria:

  • 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]

Exclusion Criteria:

  • 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

Conditions

  • Brain Spinal Tumors Medulloblastoma Relapse
  • Adult - Brain Spinal Tumors Medulloblastoma Relapse
  • Brain Spinal Tumor DIPG Relapse
  • Brain Spinal Tumor DIPG New Diagnosis
  • Adult - Brain Spinal Tumor DIPG New Diagnosis
  • Adult - Brain Spinal Tumor DIPG Relapse
  • Brain and Spinal Tumor Ependymoma Relapse
  • Adult - Brain and Spinal Tumor Ependymoma Relapse
  • Brain Spinal Other ATRT
  • Adult - Brain Spinal Other ATRT
  • Brain Spinal Other Germ Cell Tumor
  • Adult - Brain Spinal Other Germ Cell Tumor
  • Brain Spinal Other Choroid Plexus Tumor
  • Adult - Brain Spinal Other Choroid Plexus Tumor
  • Brain Spinal Other All Other
  • Adult - Brain Spinal Other All Other

Contact

For more information contact:

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati OH 45229-3039

Phone: 513-636-2799

Email: cancer@cchmc.org