EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW

EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW - EFFICACY AND SAFETY OF NIVOLUMAB IN METASTATIC RENAL CELL CANCER PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033312

Enrollment

200

Registered

2018-07-06

Start date

2018-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with RCC with distant metastasis treated with nivolumab under real clinical practice.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A patient with RCC with distant metastasis treated for the first time with nivolumab between 01 Feb 2017 and 31 Oct 2017.

Exclusion criteria

Exclusion criteria: Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMayu Kakiuchi

Mebix, Inc Oncology Group

rcc-outcome@mebix.co.jp03-4362-4504

Outcome results