NCT02545075CompletedPhase 3
A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Bristol-Myers Squibb1 site in 1 country182 target enrollmentStarted: October 31, 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Two-Years Survival Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ipilimumab
Experimental
Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression
Intervention: Ipilimumab (Drug)
Dacarbazine
Experimental
IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
Intervention: Dacarbazine (Drug)
Outcomes
Primary Outcomes
Two-Years Survival Rate
Time Frame: 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 Outcomes
- Overall Survival (OS)(Approximately 43 months)
- One-Year Survival Rate(Approximately 43 months)
- Progression Free Survival ( PFS)(Approximately 43 months)
- Disease Control Rate ( DCR )(Approximately 43 months)
- Best Overall Response Rate ( BORR )(Approximately 43 months)
- Duration of Response ( DoR)(Approximately 43 months)
- Duration of Stable Disease ( DoSD )(Approximately 43 months)
Investigators
Study Sites (1)
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