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OpenTrials
Completed

NCT Number: NCT03569436

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

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

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Key information

Conditions

Cancer of Head and Neck Cancer of the Head Cancer of the Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Tokyo, 1070052, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distribution of drug therapy treatment information

    Time frame: 6 months

  2. Distribution of non-drug therapy treatment information

    Time frame: 6 months

  3. Distribution of clinical laboratory testing

    Time frame: 6 months

  4. Distribution of participant information

    Time frame: 6 months

  5. Distribution of non-medication therapy treatment history

    Time frame: 12 months

  6. Distribution of therapeutic history

    Time frame: 12 months

  7. Overall survival

    Time frame: 12 months

  8. Progression free survival

    Time frame: 12 months

  9. Objective response rate

    Time frame: 12 months

  10. Duration of response

    Time frame: 12 months

Secondary outcomes

  1. Incidence of AE's

    Time frame: Up to 12 months

  2. Incidence of serious AE's

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharma USA Inc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2018
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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