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

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

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Chiyoda-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients who are initiating treatment with Yervoy

Exclusion criteria

Not Applicable

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Primary outcomes

The incidence of adverse events (AEs) by types among the analysis population

Time frame: 12 months
The Overall Survival (OS) Rate

Time frame: 12 months
The factors that potentially affect safety or effectiveness

Time frame: 12 months

Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

Ono Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Mar 23, 2016
Registry last updated: Feb 28, 2022

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.

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

Completed