NCT02717364

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

February 28, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

February 16, 2016

Last Update Submit

February 11, 2022

Conditions

Melanoma

Outcome Measures

Primary Outcomes (3)

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

    12 months

  • The Overall Survival (OS) Rate

    12 months

  • The factors that potentially affect safety or effectiveness

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

    12 months

Study Arms (1)

Population With Yervoy Exposure

Population With Yervoy Exposure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • All patients who are initiating treatment with Yervoy

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Chiyoda-ku, Tokyo, 1018202, Japan

Location

Local Institution

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 23, 2016

Study Start

August 27, 2015

Primary Completion

March 7, 2018

Study Completion

March 7, 2018

Last Updated

February 28, 2022

Record last verified: 2022-01

Locations

JP(2)