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Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

Completed
Conditions
Kidney Cancer
Renal Cancer
Interventions
Other: Non-Interventional
Registration Number
NCT03568435
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
212
Inclusion Criteria
  • A patient with RCC with distant metastasis treated for the first time with nivolumab
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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

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Participants with metastatic RCC taking nivolumabNon-InterventionalSpecified dose on specified day
Primary Outcome Measures
NameTimeMethod
Disease free survival36 months
Progression free survival rate36 months
Objective response rate36 months
Duration of response36 months
Incidence of adverse events36 months
Incidence of serious adverse events36 months
Overall survival status36 months
Best overall response36 months
Secondary Outcome Measures
NameTimeMethod
Distribution of socio-demographic characteristics36 months
Distribution of clinical characteristics36 months

Trial Locations

Locations (1)

Local Institution - 0001

🇯🇵

Tokyo, Japan

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