Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
NCT ID: NCT01696045
Last Updated: 2017-08-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
14 participants
INTERVENTIONAL
2012-11-12
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Ipilimumab 3 mg/kg
Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Ipilimumab
Ipilimumab 10 mg/kg
Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
Ipilimumab
Interventions
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Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
* Karnofsky Performance Status (KPS) or Lansky Score ≥ 50
Exclusion Criteria
* Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
* Symptomatic brain metastases
* History of autoimmune diseases
12 Years
17 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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Phoenix Children'S Hospital
Phoenix, Arizona, United States
Childrens Hospital Of La
Los Angeles, California, United States
Children'S Hospital Of Orange County
Orange, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania, United States
St. Jude Children'S Research Hospital
Memphis, Tennessee, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Primary Children'S Medical Center
Salt Lake City, Utah, United States
University Of Utah
Salt Lake City, Utah, United States
Local Institution
Ghent, , Belgium
Local Institution
Copenhagen, , Denmark
Local Institution
Lyon, , France
Local Institution
Marseille, , France
Local Institution
Nantes, , France
Local Institution
Villejuif, , France
Local Institution
Dortmund, , Germany
Local Institution
Erlangen, , Germany
Local Institution
Hamburg, , Germany
Local Institution
M?nster, , Germany
Local Institution
Münster, , Germany
Local Institution
México, D.F, Mexico
Local Institution
Leon, Guanajato, Guanajuato, Mexico
Local Institution
Df, Mexico City, Mexico
Local Institution
Esplugues de Llobregat- Barcelona, , Spain
Local Institution
Bristol, Avon, United Kingdom
Local Institution
Newcastle, Northumberland, United Kingdom
Local Institution
Sutton, Surrey, United Kingdom
Countries
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References
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Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2012-002249-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-178
Identifier Type: -
Identifier Source: org_study_id
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