An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Patients with High Grade Primary CNS Malignancies.
- Conditions
- Primary central nervous system (CNS) malignancies.MedDRA version: 20.0 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004441-82-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
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
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method