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

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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


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
1275 York Ave
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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3333 Burnet Avenue # Mlc3008
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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Cincinnati, OH
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1200 Moursund Street
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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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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262 Danny Thomas Pl
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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Memphis, TN
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Aurora, Colorado 80045
Phone: 720-777-6458
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 443-287-3968
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Boston, Massachusetts 02115
Phone: 617-632-5727
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Boston, MA
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171 Ashley Avenue
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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Chicago, Illinois 60614
Phone: 312-227-4810
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Gainesville, Florida 32611
Phone: 352-294-8374
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New York, New York 10032
Phone: 212-305-6254
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Randwick, New South Wales 2031
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Saint Louis, Missouri 63110
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