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
Phase:
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:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

  -  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

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