Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma
NCT ID: NCT00050102
Last Updated: 2011-01-28
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
INTERVENTIONAL
2002-10-31
2004-02-29
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
Interventions
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MDX-010 (CTLA-4)
Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.
Exclusion Criteria
* Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for \>=5 years.
* Active autoimmune disease.
* Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.
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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Arizona Cancer Center
Tucson, Arizona, United States
Pacific Shores Medical Group
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Northern California Melanoma Center
San Francisco, California, United States
Cancer Institute Medical Group
Santa Monica, California, United States
Indiana Oncology/ Hematology Consultants
Indianapolis, Indiana, United States
Piedmont Oncology Specialists
Charlotte, North Carolina, United States
Joe Arrington Cancer. Research & Treatment Center
Lubbock, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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References
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Hersh EM, O'Day SJ, Powderly J, Khan KD, Pavlick AC, Cranmer LD, Samlowski WE, Nichol GM, Yellin MJ, Weber JS. A phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy-naive patients with advanced melanoma. Invest New Drugs. 2011 Jun;29(3):489-98. doi: 10.1007/s10637-009-9376-8. Epub 2010 Jan 16.
Other Identifiers
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CA184-013
Identifier Type: OTHER
Identifier Source: secondary_id
MDX010-08
Identifier Type: -
Identifier Source: org_study_id
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