Skip to main content
OpenTrials
Completed

NCT Number: NCT03165422

A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan

Completed

Looking for future studies?

Notify Me

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

Observational

Primary location

Local Institution

Minato-ku, Tokyo, 1050001, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients > 18 years of age or older
  • Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
  • Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

Exclusion criteria

  • Patients enrolled in any clinical trials at any time
  • Overlapping use of nivolumab and ipilimumab

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Incidence of ipilimumab treatment after nivolumab treatment

    Time frame: Approximately 19 months

  2. Incidence of nivolumab treatment after ipilimumab treatment

    Time frame: Approximately 19 months

  3. Duration of nivolumab treatment

    Time frame: Approximately 19 months

  4. Duration of ipilimumab treatment

    Time frame: Approximately 19 months

  5. Duration of interval between nivolumab treatment and ipilimumab treatment

    Time frame: Approximately 19 months

Secondary outcomes

  1. overall response rate (ORR)

    Time frame: Approximately 19 months

  2. best overall response rate (BORR)

    Time frame: Approximately 19 months

  3. overall survival (OS)

    Time frame: Approximately 19 months

  4. progression-free survival (PFS)

    Time frame: Approximately 19 months

  5. incidence of treatment-related adverse events (AEs)

    Time frame: Approximately 19 months

    incidence of treatment-related adverse events (AEs)/adverse reactions (ARs)

  6. severity of treatment-related adverse events (AEs)

    Time frame: Approximately 19 months

    severity of treatment-related adverse events (AEs)/adverse reactions (ARs)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2017
Registry last updated
Oct 23, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.