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

Status: Recruiting
DFCI Protocol ID: 17-221

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

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Mark Kieran, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:


Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,

Eligibility Criteria

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

  -  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

  -  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

Know Your Options

Not sure which clinical trials might be right for your child? Email our clinical trials team at
We can help you navigate your options.

Get Clinical Trial Updates


Stay informed about Dana-Farber/Boston Children's research efforts, including information on new and current clinical trials. Sign up to receive our email newsletter Advances in Pediatric Hematology/Oncology.