Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02717364
Collaborator
Ono Pharmaceutical Co. Ltd (Industry)
556
2
30.3
278
9.2
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
556 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
Actual Study Start Date
:
Aug 27, 2015
Actual Primary Completion Date
:
Mar 7, 2018
Actual Study Completion Date
:
Mar 7, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Population With Yervoy Exposure Population With Yervoy Exposure |
Outcome Measures
Primary Outcome Measures
- 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 [12 months]
Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All patients who are initiating treatment with Yervoy
Exclusion Criteria:
- Not Applicable
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Chiyoda-ku | Tokyo | Japan | 1018202 |
| 2 | Local Institution | Tokyo | Japan |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Ono Pharmaceutical Co. Ltd
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
- BMS clinical trial educational resource
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02717364
Other Study ID Numbers:
- CA184-438
First Posted:
Mar 23, 2016
Last Update Posted:
Feb 28, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms: