Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
NCT ID: NCT00289640
Last Updated: 2010-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2006-04-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
2
Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
3
Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Interventions
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ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Ipilimumab
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Ipilimumab
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Eligibility Criteria
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Inclusion Criteria
16 Years
ALL
No
Sponsors
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Medarex
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Wilshire Oncology Medical Group Inc
Laverne, California, United States
Scripps Cancer Center
San Diego, California, United States
The Angeles Clinic And Research Institution
Santa Monica, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Oncology Specialists, Sc
Park Ridge, Illinois, United States
American Health Network
Indianapolis, Indiana, United States
University Of Louisville
Louisville, Kentucky, United States
Harry And Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
St Joseph Oncology Inc
Saint Joseph, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Local Institution
Newcastle, New South Wales, Australia
Local Institution
Brisbane, Queensland, Australia
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Heidelberg, Victoria, Australia
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Wodonga, Victoria, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Centro-Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Jaú, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Kingston, Ontario, Canada
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Olomouc, , Czechia
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Prague, , Czechia
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Brest, Cedex, France
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Clermont-Ferrand, , France
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Lyon, , France
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Lyon, , France
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Marseille, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Essen, , Germany
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Heidelberg, , Germany
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Jena, , Germany
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Kiel, , Germany
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Mannheim, , Germany
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Würzburg, , Germany
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Pécs, , Hungary
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Countries
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References
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Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.
Other Identifiers
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CA184-022
Identifier Type: -
Identifier Source: org_study_id
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