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

Completed

• Conditions: Cancer of the Head; Cancer of the Neck; Cancer of Head and Neck

• Registration Number: NCT03569436
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of AE's	Up to 12 months
Incidence of serious AE's	Up to 12 months

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tokyo, Japan