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NCT03568435 Clinical Trial

Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

Kidney Cancer Clinical Trial

Official title:
Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03568435
Other study ID # CA209-8D3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 14, 2018
Est. completion date December 21, 2020

Study information
Verified date October 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer

Recruitment information / eligibility
Status Completed
Enrollment 212
Est. completion date December 21, 2020
Est. primary completion date December 21, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
Japan Local Institution - 0001 Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharma USA Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival status 6 months
Primary Overall survival status 36 months
Primary Best overall response 6 months
Primary Best overall response 36 months
Primary Progression free survival rate 6 months
Primary Progression free survival rate 36 months
Primary Disease free survival 6 months
Primary Disease free survival 36 months
Primary Objective response rate 6 months
Primary Objective response rate 36 months
Primary Duration of response 6 months
Primary Duration of response 36 months
Primary Incidence of adverse events 36 months
Primary Incidence of serious adverse events 36 months
Secondary Distribution of clinical characteristics 36 months
Secondary Distribution of socio-demographic characteristics 36 months
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