An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 4/5/2019 |
Start Date: | June 6, 2017 |
End Date: | June 15, 2021 |
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
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
in combination with ipilimumab in pediatric patients with high grade primary central nervous
system (CNS) malignancies
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 found this trial at
15
sites
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 832-824-4570
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Phone: 901-595-2057
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 843-732-2957
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-5720
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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