A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
1 other identifier
interventional
182
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
October 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2019
CompletedResults Posted
Study results publicly available
May 19, 2020
CompletedMay 19, 2020
May 1, 2020
3.5 years
August 25, 2015
April 14, 2020
May 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
One-Year Survival Rate
Approximately 43 months
Overall Survival (OS)
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
- +2 more secondary outcomes
Study Arms (2)
Ipilimumab
EXPERIMENTALIntravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression
Dacarbazine
EXPERIMENTALIV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Local Institution
Nanjing, Jiangsu, 210000, China
Local Institution
Changchun, Jilin, 130021, China
Local Institution
Xi’an, Shanxi, 710038, China
Local Institution
Tianjin, Tianjin Municipality, 300060, China
Local Institution
Hanghzou, Zhejiang, China
Local Institution
Beijing, 100142, China
Local Institution
Kunming, China
Local Institution
Shanghai, 200032, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2015
First Posted
September 9, 2015
Study Start
October 31, 2015
Primary Completion
April 19, 2019
Study Completion
April 19, 2019
Last Updated
May 19, 2020
Results First Posted
May 19, 2020
Record last verified: 2020-05