A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
NCT ID: NCT00289627
Last Updated: 2016-09-28
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
155 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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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ipilimumab (MDX-010, BMS-734016)
ipilimumab (MDX-010, BMS-734016)
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, 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
18 Years
ALL
No
Sponsors
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Medarex
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Little Rock, Arkansas, United States
San Francisco, California, United States
Santa Monica, California, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Goshen, Indiana, United States
Hazard, Kentucky, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Portland, Oregon, United States
Greenville, South Carolina, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Charlottesvillle, Virginia, United States
Local Institution
Salzburg, , Austria
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Vienna, , Austria
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Wels, , Austria
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Turku, , Finland
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Genova, , Italy
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Meldola, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Siena, , Italy
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Torino, , Italy
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Oslo, , Norway
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Lodz, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Barnaul, , Russia
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Moscow, , Russia
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Murmansk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Stavropol, , Russia
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Veliky Novgorod, , Russia
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Voronezh, , Russia
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Santa Cruz de Tenerife, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Cherkassy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Kiev, , Ukraine
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Lviv, , Ukraine
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Sumy, , Ukraine
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Uzhhorod, , Ukraine
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.
Di Giacomo AM, Danielli R, Guidoboni M, Calabro L, Carlucci D, Miracco C, Volterrani L, Mazzei MA, Biagioli M, Altomonte M, Maio M. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother. 2009 Aug;58(8):1297-306. doi: 10.1007/s00262-008-0642-y. Epub 2009 Jan 13.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA184-008
Identifier Type: -
Identifier Source: org_study_id
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