A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Ipilimumab
* Drug: Dacarbazine


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Chinese males and females ≥ 18 years of age Histologic diagnosis of malignant melanoma Chemotherapy naive Stage IV melanoma (AJCC 2010) Life expectancy of ≥ 16 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Evidence of brain metastases on brain imaging Primary ocular or mucosal melanoma Any other malignancy from which the patient has been disease-free for less than 5 years BRAF status cannot be determined by Screening test Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipilimumab<br>Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression | Drug: Ipilimumab<br> <br> * Other names: MDX-010;|
| Experimental: Dacarbazine<br>IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22) | Drug: Dacarbazine<br> <br> * Other names: DTIC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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. | 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. | Approximately 43 months | 
| Duration of Response ( DoR) | 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). | 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). | Approximately 43 months |