Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread

January 27, 2022 updated by: Bristol-Myers Squibb

Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review

Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

262

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

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

Recurrent/Metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) participants on nivolumab who progressed on or after platinum therapy

Description

Inclusion Criteria:

  • Recurrent/metastatic HNC patients with disease progression on or after a platinum-based therapy treated with nivolumab at least once from 01-Jul-2017 through 31-Dec-2017

Exclusion Criteria:

  • History of participation in any clinical trials prior- or post-nivolumab treatment

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
Metastatic head and neck participants in Japan
Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 12 months
12 months
Overall survival
Time Frame: 12 months
12 months
Duration of response
Time Frame: 12 months
12 months
Distribution of drug therapy treatment information
Time Frame: 6 months
6 months
Distribution of non-drug therapy treatment information
Time Frame: 6 months
6 months
Distribution of clinical laboratory testing
Time Frame: 6 months
6 months
Distribution of participant information
Time Frame: 6 months
6 months
Distribution of non-medication therapy treatment history
Time Frame: 12 months
12 months
Distribution of therapeutic history
Time Frame: 12 months
12 months
Objective response rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of AE's
Time Frame: Up to 12 months
Up to 12 months
Incidence of serious AE's
Time Frame: Up to 12 months
Up to 12 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.

General Publications

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)

June 26, 2020

Study Completion (ACTUAL)

June 26, 2020

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8DD

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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