A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
NCT ID: NCT03130959
Last Updated: 2022-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
166 participants
INTERVENTIONAL
2017-06-12
2022-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Module A
Nivolumab
Specified dose on specified days
Module B
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy
* A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT
* A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy
* A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT
* A histologically-confirmed high grade CNS malignancy "other than above" which is recurrent or progressive after at least one line of prior therapy
* 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
* A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
6 Months
21 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0057
Los Angeles, California, United States
Local Institution - 0016
Aurora, Colorado, United States
Local Institution - 0046
Gainesville, Florida, United States
Local Institution - 0011
Chicago, Illinois, United States
Local Institution - 0005
Baltimore, Maryland, United States
Local Institution - 0043
Boston, Massachusetts, United States
Local Institution - 0044
St Louis, Missouri, United States
Local Institution - 0004
New York, New York, United States
Local Institution - 0017
New York, New York, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Local Institution - 0066
Philadelphia, Pennsylvania, United States
Local Institution
Charleston, South Carolina, United States
Local Institution - 0012
Memphis, Tennessee, United States
Local Institution - 0042
Houston, Texas, United States
Local Institution - 0022
Randwick, New South Wales, Australia
Local Institution - 0035
Sth Brisbane, Queensland, Australia
Local Institution
Clayton, Victoria, Australia
Local Institution - 0034
Parkville, Victoria, Australia
Local Institution - 0033
Nedlands, Western Australia, Australia
Local Institution - 0052
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0051
Barretos, São Paulo, Brazil
Local Institution - 0053
Ribeirão Preto, São Paulo, Brazil
Local Institution - 0049
São Paulo, , Brazil
Local Institution - 0050
São Paulo, , Brazil
Local Institution - 0021
Toronto, Ontario, Canada
Local Institution - 0001
Montreal, Quebec, Canada
Local Institution - 0002
Québec, Quebec, Canada
Local Institution - 0028
Angers, , France
Local Institution - 0029
Bordeaux, , France
Local Institution - 0027
Lille, , France
Local Institution - 0025
Lyon, , France
Local Institution - 0024
Marseille, , France
Local Institution - 0023
Paris, , France
Local Institution - 0064
Vandœuvre-lès-Nancy, , France
Local Institution - 0026
VIillejuif, , France
Local Institution - 0060
Essen, , Germany
Local Institution - 0061
Hamburg, , Germany
Local Institution - 0063
Heidelberg, , Germany
Local Institution - 0062
Würzburg, , Germany
Local Institution - 0018
Hong Kong, , Hong Kong
Local Institution - 0059
Haifa, , Israel
Local Institution - 0058
Ramat Gan, , Israel
Local Institution - 0007
Rotterdam, , Netherlands
Local Institution - 0008
Utrecht, , Netherlands
Local Institution - 0067
Oslo, , Norway
Local Institution - 0047
Warsaw, , Poland
Local Institution - 0048
Moscow, , Russia
Local Institution - 0037
Esplugues de Llobregat, , Spain
Local Institution - 0038
Madrid, , Spain
Local Institution - 0036
Valencia, , Spain
Local Institution - 0065
Solna, , Sweden
Local Institution - 0010
London, Greater London, United Kingdom
Local Institution - 0013
Liverpool, Merseyside, United Kingdom
Local Institution - 0015
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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References
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Dunkel IJ, Doz F, Foreman NK, Hargrave D, Lassaletta A, Andre N, Hansford JR, Hassall T, Eyrich M, Gururangan S, Bartels U, Gajjar A, Howell L, Warad D, Pacius M, Tam R, Wang Y, Zhu L, Cohen K. Nivolumab with or without ipilimumab in pediatric patients with high-grade CNS malignancies: Safety, efficacy, biomarker, and pharmacokinetics-CheckMate 908. Neuro Oncol. 2023 Aug 3;25(8):1530-1545. doi: 10.1093/neuonc/noad031.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-004441-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-908
Identifier Type: -
Identifier Source: org_study_id
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