Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

October 19, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1070052
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with RCC with distant metastasis treated with nivolumab under real clinical practice

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with metastatic RCC taking nivolumab
Specified dose on specified day
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 6 months
6 months
Duration of response
Time Frame: 6 months
6 months
Objective response rate
Time Frame: 36 months
36 months
Duration of response
Time Frame: 36 months
36 months
Best overall response
Time Frame: 6 months
6 months
Overall survival status
Time Frame: 6 months
6 months
Overall survival status
Time Frame: 36 months
36 months
Best overall response
Time Frame: 36 months
36 months
Progression free survival rate
Time Frame: 6 months
6 months
Progression free survival rate
Time Frame: 36 months
36 months
Disease free survival
Time Frame: 6 months
6 months
Disease free survival
Time Frame: 36 months
36 months
Incidence of adverse events
Time Frame: 36 months
36 months
Incidence of serious adverse events
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of clinical characteristics
Time Frame: 36 months
36 months
Distribution of socio-demographic characteristics
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharma USA Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2018

Primary Completion (ACTUAL)

December 21, 2020

Study Completion (ACTUAL)

December 21, 2020

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8D3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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