Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03568435
Collaborator
Ono Pharma USA Inc (Industry)
212
1
34.2
6.2
Study Details
Study Description
Brief Summary
A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
212 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review
Actual Study Start Date
:
Feb 14, 2018
Actual Primary Completion Date
:
Dec 21, 2020
Actual Study Completion Date
:
Dec 21, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with metastatic RCC taking nivolumab Specified dose on specified day |
Other: Non-Interventional
Non-Interventional
|
Outcome Measures
Primary Outcome Measures
- Overall survival status [6 months]
- Overall survival status [36 months]
- Best overall response [6 months]
- Best overall response [36 months]
- Progression free survival rate [6 months]
- Progression free survival rate [36 months]
- Disease free survival [6 months]
- Disease free survival [36 months]
- Objective response rate [6 months]
- Objective response rate [36 months]
- Duration of response [6 months]
- Duration of response [36 months]
- Incidence of adverse events [36 months]
- Incidence of serious adverse events [36 months]
Secondary Outcome Measures
- Distribution of clinical characteristics [36 months]
- Distribution of socio-demographic characteristics [36 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- A patient with RCC with distant metastasis treated for the first time with nivolumab
Exclusion Criteria:
- Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Tokyo | Japan | 1070052 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Ono Pharma USA Inc
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03568435
Other Study ID Numbers:
- CA209-8D3
First Posted:
Jun 26, 2018
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: