Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
NCT ID: NCT00261365
Last Updated: 2016-09-29
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
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2005-11-30
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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A1
Ipilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
A2
Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Interventions
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Ipilimumab
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Ipilimumab
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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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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Comprehensive Cancer Center
Palm Springs, California, United States
The Angeles Clinic And Research Institution
Santa Monica, California, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Local Institution
Aarhus C, , Denmark
Local Institution
Odense C, , Denmark
Local Institution
Jerusalem, , Israel
Local Institution
Bari, , Italy
Local Institution
Forlì, , Italy
Local Institution
Ravenna, , Italy
Local Institution
Rimini, , Italy
Local Institution
Oslo, , Norway
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Gothenberg, , Sweden
Local Institution
Stockholm, , Sweden
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.
Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204.
Other Identifiers
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CA184-004
Identifier Type: -
Identifier Source: org_study_id
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