An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies

Description

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

Study Start Date

June, 06 2017

Estimated Completion Date

June 2021

Interventions

  • Biological: Nivolumab
  • Biological: Ipilimumab

Study ID

Bristol-Myers Squibb -- CA209-908

Status

Recruiting

Trial ID

NCT03130959

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

170

Sponsor

Bristol-Myers Squibb

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)
  • High Grade Glioma (HGG)
  • Medulloblastoma
  • Ependymoma
  • Other high-grade tumors of the central nervous system
  • 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

Gender

All

Ages

6 Months to 21 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (116)

Study Location Distance Name Phone Email
DanaFarber Cancer Inst - Boston, Massachusetts 2.4 miles Mark Kieran Site 0043 None None
DanaFarber Cancer Inst - Boston, Massachusetts 2.4 miles Mark Kieran Site 0043 None None
DanaFarber Cancer Inst - Boston, Massachusetts 2.4 miles Mark Kieran Site 0043 None None
DanaFarber Cancer Inst - Boston, Massachusetts 2.4 miles Mark Kieran Site 0043 None None
DanaFarber Cancer Inst - Boston, Massachusetts 2.4 miles Mark Kieran Site 0043 None None
The Herbert Irving Pavilion - New York, New York 181.2 miles Julia GladeBender Site 0017 None None
The Herbert Irving Pavilion - New York, New York 181.2 miles Julia GladeBender Site 0017 None None
The Herbert Irving Pavilion - New York, New York 181.2 miles Julia GladeBender Site 0017 None None
The Herbert Irving Pavilion - New York, New York 181.2 miles Julia GladeBender Site 0017 None None
The Herbert Irving Pavilion - New York, New York 181.2 miles Julia GladeBender Site 0017 None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Ira Dunkel Site 0004 None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Ira Dunkel Site 0004 None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Ira Dunkel Site 0004 None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Ira Dunkel Site 0004 None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Ira Dunkel Site 0004 None None
The Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kenneth Cohen Site 0005 None None
The Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kenneth Cohen Site 0005 None None
The Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kenneth Cohen Site 0005 None None
The Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kenneth Cohen Site 0005 None None
The Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Kenneth Cohen Site 0005 None None
ChildrenS Memorial Hospital - Chicago, Illinois 849.3 miles Stewart Goldman Site 0011 None None
ChildrenS Memorial Hospital - Chicago, Illinois 849.3 miles Stewart Goldman Site 0011 None None
ChildrenS Memorial Hospital - Chicago, Illinois 849.3 miles Stewart Goldman Site 0011 None None
ChildrenS Memorial Hospital - Chicago, Illinois 849.3 miles Stewart Goldman Site 0011 None None
ChildrenS Memorial Hospital - Chicago, Illinois 849.3 miles Stewart Goldman Site 0011 None None
Mcknight Brain Institute - Gainesville, Florida 1,081.1 miles Sridrahan Gururangan Site 0046 None None
Mcknight Brain Institute - Gainesville, Florida 1,081.1 miles Sridrahan Gururangan Site 0046 None None
Mcknight Brain Institute - Gainesville, Florida 1,081.1 miles Sridrahan Gururangan Site 0046 None None
Mcknight Brain Institute - Gainesville, Florida 1,081.1 miles Sridrahan Gururangan Site 0046 None None
Mcknight Brain Institute - Gainesville, Florida 1,081.1 miles Sridrahan Gururangan Site 0046 None None
St Jude ChildrenS Research Hospital - Memphis, Tennessee 1,134.7 miles Amar Gajjar Site 0012 None None
St Jude ChildrenS Research Hospital - Memphis, Tennessee 1,134.7 miles Amar Gajjar Site 0012 None None
St Jude ChildrenS Research Hospital - Memphis, Tennessee 1,134.7 miles Amar Gajjar Site 0012 None None
St Jude ChildrenS Research Hospital - Memphis, Tennessee 1,134.7 miles Amar Gajjar Site 0012 None None
St Jude ChildrenS Research Hospital - Memphis, Tennessee 1,134.7 miles Amar Gajjar Site 0012 None None
Baylor College Of Medicine - Houston, Texas 1,609.9 miles Patricia Baxter Site 0042 None None
Baylor College Of Medicine - Houston, Texas 1,609.9 miles Patricia Baxter Site 0042 None None
Baylor College Of Medicine - Houston, Texas 1,609.9 miles Patricia Baxter Site 0042 None None
Baylor College Of Medicine - Houston, Texas 1,609.9 miles Patricia Baxter Site 0042 None None
Baylor College Of Medicine - Houston, Texas 1,609.9 miles Patricia Baxter Site 0042 None None
ChildrenS Hospital - Aurora, Colorado 1,759.8 miles Nicholas Foreman Site 0016 None None
ChildrenS Hospital - Aurora, Colorado 1,759.8 miles Nicholas Foreman Site 0016 None None
ChildrenS Hospital - Aurora, Colorado 1,759.8 miles Nicholas Foreman Site 0016 None None
ChildrenS Hospital - Aurora, Colorado 1,759.8 miles Nicholas Foreman Site 0016 None None
ChildrenS Hospital - Aurora, Colorado 1,759.8 miles Nicholas Foreman Site 0016 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0057 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0041 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0044 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0020 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0040 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0006 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0045 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0022 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0035 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0035 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0030 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0030 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0034 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0034 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0033 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0033 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0054 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0054 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0052 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0052 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0051 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0051 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0053 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0053 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0049 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0049 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0050 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0050 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0003 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0021 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0028 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0027 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0025 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0024 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0023 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0064 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0026 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0060 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0061 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0063 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0062 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0018 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0008 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0056 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0037 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0038 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0036 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0015 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0014 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0003 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0021 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0028 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0029 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0027 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0025 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0024 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0023 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0064 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0026 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0060 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0061 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0018 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0008 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0007 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0047 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0056 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0037 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0038 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0036 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0015 None None
Local Institution - Los Angeles, California 2,595.3 miles Site 0014 None None

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