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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545075
• Other study ID #: CA184-248
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2015
• Est. completion date: April 19, 2019

Study information

• Verified date: May 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Ipilimumab

• Dacarbazine

Locations

Country	Name	City	State
China	Local Institution	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Hanghzou	Zhejiang
China	Local Institution	Kunming
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai
China	Local Institution	Tianjing	Tianjin
China	Local Institution	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS clinical trial educational resource
•   Investigator Inquiry form