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

October 21, 2019 updated by: Bristol-Myers Squibb
This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1050001
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with melanoma who are patients at the participating centers in Japan will be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with melanoma
Adult patients with melanoma at participating centers in Japan
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ipilimumab treatment after nivolumab treatment
Time Frame: Approximately 19 months
Approximately 19 months
Incidence of nivolumab treatment after ipilimumab treatment
Time Frame: Approximately 19 months
Approximately 19 months
Duration of nivolumab treatment
Time Frame: Approximately 19 months
Approximately 19 months
Duration of ipilimumab treatment
Time Frame: Approximately 19 months
Approximately 19 months
Duration of interval between nivolumab treatment and ipilimumab treatment
Time Frame: Approximately 19 months
Approximately 19 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate (ORR)
Time Frame: Approximately 19 months
Approximately 19 months
best overall response rate (BORR)
Time Frame: Approximately 19 months
Approximately 19 months
overall survival (OS)
Time Frame: Approximately 19 months
Approximately 19 months
progression-free survival (PFS)
Time Frame: Approximately 19 months
Approximately 19 months
incidence of treatment-related adverse events (AEs)
Time Frame: Approximately 19 months
incidence of treatment-related adverse events (AEs)/adverse reactions (ARs)
Approximately 19 months
severity of treatment-related adverse events (AEs)
Time Frame: Approximately 19 months
severity of treatment-related adverse events (AEs)/adverse reactions (ARs)
Approximately 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

December 29, 2018

Study Completion (ACTUAL)

December 29, 2018

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (ACTUAL)

May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9DA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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