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: 20.0Level: LLTClassification code 10006153Term: Brain tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004441-82-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- 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 Main Objective: To estimate anti-tumor activity of study treatments, based on duration of disease control and survival, of children and adolescents with CNS malignancies.;Secondary Objective: To describe the safety and tolerability of study treatments in children and adolescents with CNS malignancies.;Primary end point(s): 1- Safety Lead In: Safety and tolerability: DLTs, SAEs, AEs leading to discontinuation;<br>2- Diffuse Intrinsic Pontine Glioma (DIPG): Overall Survival (OS);<br>3- All other tumor types: Progression Free Survival (PFS).;Timepoint(s) of evaluation of this end point: Approximately 6 weeks for (1); Approximately 3 years (from first patient treated) for (2); Approximately 2 years for (3)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Safety: AEs, SAEs, drug-related AEs, AEs leading to discontinuation, and death. Incidence of laboratory abnormalities;<br>2- Diffuse Intrinsic Pontine Glioma (DIPG): Progression Free Survival (PFS);<br>3- Diffuse Intrinsic Pontine Glioma (DIPG): Overall Survival at 12 month point (OS(12));<br>4- High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors: Progression Free Survival at 6 months (PFS(6));<br>5- High Grade Glioma (HGG), Medulloblastoma, Ependymoma, and other high-grade CNS tumors: Overall Survival (OS);<br>6- High Grade Glioma (HGG), Medulloblastoma, Ependymoma: Overall Survival at 12 month point (OS(12)).;Timepoint(s) of evaluation of this end point: Approximately 3 years for (1) and (5); Approximately 18 months to 2 years from first patient treated for (2) and (4); Approximately 24 months to 3 years for (3) and (6).