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NCT03165422 Clinical Trial

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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03165422
Other study ID # CA209-9DA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date December 29, 2018

Study information
Verified date October 2019
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 29, 2018
Est. primary completion date December 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
Japan Local Institution Minato-ku Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ipilimumab treatment after nivolumab treatment Approximately 19 months
Primary Incidence of nivolumab treatment after ipilimumab treatment Approximately 19 months
Primary Duration of nivolumab treatment Approximately 19 months
Primary Duration of ipilimumab treatment Approximately 19 months
Primary Duration of interval between nivolumab treatment and ipilimumab treatment Approximately 19 months
Secondary overall response rate (ORR) Approximately 19 months
Secondary best overall response rate (BORR) Approximately 19 months
Secondary overall survival (OS) Approximately 19 months
Secondary progression-free survival (PFS) Approximately 19 months
Secondary incidence of treatment-related adverse events (AEs) incidence of treatment-related adverse events (AEs)/adverse reactions (ARs) Approximately 19 months
Secondary severity of treatment-related adverse events (AEs) severity of treatment-related adverse events (AEs)/adverse reactions (ARs) Approximately 19 months
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