A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread

February 9, 2022 updated by: Bristol-Myers Squibb

Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)

Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

81

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, 170-8630
        • Local Institution

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo

Description

Inclusion Criteria:

  • Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS

Exclusion Criteria:

  • Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS

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
Patients taking combination therapy with Yervoy and Opdivo
Medical records will be reviewed for safety and treatments for specific ADR
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of immune-related AE's
Time Frame: Approximately 13 weeks
Approximately 13 weeks
Incidence of immune related SAE's
Time Frame: Approximately 13 weeks
Approximately 13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment for immune-related adverse reactions
Time Frame: Approximately 13 weeks
Approximately 13 weeks
Incidence of unknown AE's
Time Frame: Approximately 13 weeks
Approximately 13 weeks
Incidence of unknown SAE's
Time Frame: Approximately 13 weeks
Approximately 13 weeks

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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)

September 18, 2018

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8MK

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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