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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ipilimumab
Dacarbazine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ipilimumab

Dacarbazine

Arm Description

Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression

IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall Survival (OS)
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
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.
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.
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.
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).
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)."

Full Information

First Posted
August 25, 2015
Last Updated
May 5, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02545075
Brief Title
A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2015 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab
Arm Type
Experimental
Arm Description
Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression
Arm Title
Dacarbazine
Arm Type
Experimental
Arm Description
IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
MDX-010
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Other Intervention Name(s)
DTIC
Primary Outcome Measure Information:
Title
Two-Years Survival Rate
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
One-Year Survival Rate
Description
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.
Time Frame
Approximately 43 months
Title
Overall Survival (OS)
Description
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
Time Frame
Approximately 43 months
Title
Progression Free Survival ( PFS)
Description
PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
Time Frame
Approximately 43 months
Title
Disease Control Rate ( DCR )
Description
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.
Time Frame
Approximately 43 months
Title
Best Overall Response Rate ( BORR )
Description
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.
Time Frame
Approximately 43 months
Title
Duration of Response ( DoR)
Description
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).
Time Frame
Approximately 43 months
Title
Duration of Stable Disease ( DoSD )
Description
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)."
Time Frame
Approximately 43 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution
City
Tianjing
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution
City
Hanghzou
State/Province
Zhejiang
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution
City
Kunming
Country
China
Facility Name
Local Institution
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Links:
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS clinical trial educational resource

Learn more about this trial

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

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