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Summary

for people ages 6 months to 21 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies

Keywords

Various Advanced Cancer Nivolumab Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 6 months to 21 years

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]

You CAN'T join if...

  • 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

Locations

  • Local Institution not yet accepting patients
    San Francisco, California, 94158, United States
  • Children's Hospital Of Los Angeles accepting new patients
    Los Angeles, California, 90027, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT03130959
Phase
Phase 2
Lead Scientist
Sabine Mueller
Study Type
Interventional
Last Updated
April 9, 2018
I’m interested in this study!