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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Cancer of the Head
• Cancer of the Neck
• Head and Neck Neoplasms

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form