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

Completed

• Conditions: Melanoma
• Interventions: Other: Non-Interventional

• Registration Number: NCT03165422
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Primary Completion: 2018-12-29
• Study Completion: 2018-12-29
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with melanoma	Non-Interventional	Adult patients with melanoma at participating centers in Japan

Primary Outcome Measures

Name	Time	Method
Incidence of ipilimumab treatment after nivolumab treatment	Approximately 19 months
Incidence of nivolumab treatment after ipilimumab treatment	Approximately 19 months
Duration of nivolumab treatment	Approximately 19 months
Duration of ipilimumab treatment	Approximately 19 months
Duration of interval between nivolumab treatment and ipilimumab treatment	Approximately 19 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Minato-ku, Tokyo, Japan