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NCT03569436 Clinical Trial

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

Cancer of Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03569436
Other study ID # CA209-8DD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 14, 2018
Est. completion date June 26, 2020

Study information
Verified date January 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 262
Est. completion date June 26, 2020
Est. primary completion date June 26, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Local Institution Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharma USA Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of drug therapy treatment information 6 months
Primary Distribution of non-drug therapy treatment information 6 months
Primary Distribution of clinical laboratory testing 6 months
Primary Distribution of participant information 6 months
Primary Distribution of non-medication therapy treatment history 12 months
Primary Distribution of therapeutic history 12 months
Primary Overall survival 12 months
Primary Progression free survival 12 months
Primary Objective response rate 12 months
Primary Duration of response 12 months
Secondary Incidence of AE's Up to 12 months
Secondary Incidence of serious AE's Up to 12 months
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