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Active, Not 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: 29 March, 2021   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's 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


  • Gender(s)

  • Active, Not Recruiting

Treatment Options

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

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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