EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Not Applicable
- Conditions
- Patients with RCC with distant metastasis treated with nivolumab under real clinical practice.
- Registration Number
- JPRN-UMIN000033312
- Lead Sponsor
- Bristol-Myers Squibb Ono Pharmaceutical CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe actual usage and pattern of nivolumab in advanced/metastatic RCC patients in clinical practice; such as treatment frequency, treatment-history before and after nivolumab use, treatment period, treatment line, changes related to management of adverse events (AEs), etc To assess overall effectiveness (overall survival [OS], progression-free survival [PFS], objective response rate [ORR], duration of response [DOR]) and safety of nivolumab in advanced/metastatic RCC patients
- Secondary Outcome Measures
Name Time Method Effectiveness and safety by special subgroup; brain metastasis and non-clear cell RCC etc Effectiveness and safety in post-nivolumab treatment; treatment-history, regimen/response/AE etc