The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Local Institution
Nanjing, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Xi’an, Shanxi, China
Local Institution
Tianjin, Tianjin Municipality, China
Two-Years Survival Rate
Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
Time frame: 24 months
One-Year Survival Rate
Survival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
Time frame: Approximately 43 months
Overall Survival (OS)
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
Time frame: Approximately 43 months
Progression Free Survival ( PFS)
PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
Time frame: Approximately 43 months
Disease Control Rate ( DCR )
Primary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm.
Time frame: Approximately 43 months
Best Overall Response Rate ( BORR )
BORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm.
Time frame: Approximately 43 months
Duration of Response ( DoR)
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Local Institution
Hanghzou, Zhejiang, China
Local Institution
Beijing, China
Local Institution
Kunming, China
Local Institution
Shanghai, China
DoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first).
Time frame: Approximately 43 months
Duration of Stable Disease ( DoSD )
Primary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)."
Time frame: Approximately 43 months