The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
estimate disease control rate
estimate progression free survival rate at Week 12
estimate PFS
estimate overall survival
estimate survival rate at one year
estimate duration of BOR
evaluate proportion of patients whose duration of response is >=24 weeks
estimate time to BOR
evaluate safety profile of ipilimumab during the induction and maintenance phases
evaluate health-related quality of life
obtain PK sample for population PK analysis
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Little Rock, Arkansas, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Goshen, Indiana, United States
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Hazard, Kentucky, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Portland, Oregon, United States
...and 43 more locations