Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Completed

• Conditions: Melanoma

• Registration Number: NCT02717364
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-27
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-23
• Primary Completion: 2018-03-07
• Study Completion: 2018-03-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• All patients who are initiating treatment with Yervoy

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Exclusion Criteria

• Not Applicable

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Overall Survival (OS) Rate	12 months
The factors that potentially affect safety or effectiveness	12 months	Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background
The incidence of adverse events (AEs) by types among the analysis population	12 months

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tokyo, Japan