A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
- Registration Number
- NCT02545075
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ipilimumab Ipilimumab Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression Dacarbazine Dacarbazine IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
- Primary Outcome Measures
Name Time Method Two-Years Survival Rate 24 months 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Approximately 43 months OS is defined for each subject as the time between randomization date and the date of death (of any cause).
One-Year Survival Rate Approximately 43 months 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.
Progression Free Survival ( PFS) Approximately 43 months PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
Disease Control Rate ( DCR ) Approximately 43 months 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.
Best Overall Response Rate ( BORR ) Approximately 43 months 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.
Duration of Response ( DoR) Approximately 43 months 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).
Duration of Stable Disease ( DoSD ) Approximately 43 months 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)."
Trial Locations
- Locations (1)
Local Institution
🇨🇳Shanghai, China