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NCT Number: NCT02545075

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Drug

Other names: MDX-010

Dacarbazine

Drug

Other names: DTIC

Primary outcomes

  1. 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

  1. One-Year Survival Rate

    Time frame: 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.

  2. Overall Survival (OS)

    Time frame: Approximately 43 months

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

  3. Progression Free Survival ( PFS)

    Time frame: 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.

  4. Disease Control Rate ( DCR )

    Time frame: 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.

  5. Best Overall Response Rate ( BORR )

    Time frame: 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.

  6. Duration of Response ( DoR)

    Time frame: 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).

  7. Duration of Stable Disease ( DoSD )

    Time frame: 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)."

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2015
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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