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Recruiting

An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies - CA209-908

Updated: 02 August, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 29

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Module A
Biological: Nivolumab
Experimental: Module B
Biological: Nivolumab Biological: Ipilimumab

Key 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), 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

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us