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
158 participants
INTERVENTIONAL
2008-03-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
0.1 mg/kg every 3 weeks
Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Arm 2
1 mg/kg every 3 weeks
Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Arm 3
1 mg/kg every 6 weeks
Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Arm 4
5 mg/kg every 3 weeks
Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Interventions
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Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Eligibility Criteria
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Inclusion Criteria
* Men and women, who are at least 18 years of age
Exclusion Criteria
* Complete surgical resection of all identifiable sites of disease
* Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
18 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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The Angeles Clinic & Research Institute
Los Angeles, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Indiana University Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States
Harry & Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, United States
Dana-Farber Cancer Inst
Boston, Massachusetts, United States
Mem Sloan-Ket Can Ctr
New York, New York, United States
Blumenthal Cancer Center, Carolinas Medical Center
Charlotte, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
University Of Texas
Houston, Texas, United States
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Aarhus C, , Denmark
Local Institution
Odense C, , Denmark
Local Institution
Lille, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Villejuif, , France
Local Institution
Homburg / Saar, , Germany
Local Institution
Jena, , Germany
Local Institution
Kiel, , Germany
Local Institution
Mainz, , Germany
Local Institution
Mannheim, , Germany
Local Institution
Tübingen, , Germany
Local Institution
Würzburg, , Germany
Local Institution
Genove, , Italy
Local Institution
Milan, , Italy
Local Institution
Napoli, , Italy
Local Institution
Padua, , Italy
Local Institution
Siena, , Italy
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA186-006
Identifier Type: -
Identifier Source: org_study_id
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