Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03569436
Collaborator
Ono Pharma USA Inc (Industry)
262
Enrollment
1
Location
28.4
Actual Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    262 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review
    Actual Study Start Date :
    Feb 14, 2018
    Actual Primary Completion Date :
    Jun 26, 2020
    Actual Study Completion Date :
    Jun 26, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Metastatic head and neck participants in Japan

    Study in Japan targeting recurrent/metastatic HNC patients who are treated with nivolumab

    Outcome Measures

    Primary Outcome Measures

    1. Distribution of drug therapy treatment information [6 months]

    2. Distribution of non-drug therapy treatment information [6 months]

    3. Distribution of clinical laboratory testing [6 months]

    4. Distribution of participant information [6 months]

    5. Distribution of non-medication therapy treatment history [12 months]

    6. Distribution of therapeutic history [12 months]

    7. Overall survival [12 months]

    8. Progression free survival [12 months]

    9. Objective response rate [12 months]

    10. Duration of response [12 months]

    Secondary Outcome Measures

    1. Incidence of AE's [Up to 12 months]

    2. Incidence of serious AE's [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Tokyo Japan 1070052

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Ono Pharma USA Inc

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03569436
    Other Study ID Numbers:
    • CA209-8DD
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Feb 10, 2022