Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
NCT ID: NCT01990859
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2013-12-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A: Ipilimumab
Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses
Ipilimumab
Interventions
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Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously-treated or untreated unresectable Stage III or Stage IV melanoma
* Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Primary ocular or mucosal melanoma
* History of or current active autoimmune disease
20 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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Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kumamoto, Kumamoto, Japan
Local Institution
Matsumoto-shi, Nagano, Japan
Local Institution
Sunto-gun, Shizuoka, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Local Institution
Chuo-shi, Yamanashi, Japan
Countries
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References
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Yamazaki N, Kiyohara Y, Uhara H, Fukushima S, Uchi H, Shibagaki N, Tsutsumida A, Yoshikawa S, Okuyama R, Ito Y, Tokudome T. Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):997-1004. doi: 10.1007/s00280-015-2873-x. Epub 2015 Sep 26.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA184-396
Identifier Type: -
Identifier Source: org_study_id
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