EUCTR2016-004441-82-DE
Active, not recruiting
Phase 1
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies - CheckMate908
Bristol-Myers Squibb International Corporation0 sites200 target enrollmentStarted: June 19, 2017Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 200
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\-Children and adolescents diagnosed with either:
- •\_Diffuse Intrinsic Pontine Glioma (DIPG),
- •\_High Grade Glioma (HGG),
- •\_Medulloblastoma,
- •\_Ependymoma, or
- •\_Other high\-grade tumors of the central nervous system.
- •2\-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\.
- •3\-A tumor sample must be available for submission to central laboratory \[not required for DIPG].
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
Exclusion Criteria
- •1\-Participants with active, known or suspected autoimmune disease.
- •2\-Participants unable to taper steroids due to ongoing mass effect.
- •3\-Participants with low\-grade gliomas or tumors of unknown malignant potential.
- •4\-Prior treatment with any drug that targets T cell co\-stimulation pathways (such as checkpoint inhibitors).
Investigators
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