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.orgEligibility 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