A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China
NCT ID: NCT04825873
Last Updated: 2023-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3102 participants
OBSERVATIONAL
2021-05-28
2023-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort 1
Prospective observation of participants with non-small cell lung cancer (NSCLC)
No interventions assigned to this group
Cohort 2
Prospective observation of participants with squamous cell carcinoma of head and neck (SCCHN)
No interventions assigned to this group
Cohort 3
Retrospective observation of participants with NSCLC
No interventions assigned to this group
Cohort 4
Retrospective observation of participants with SCCHN
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of locally advanced/metastatic non-small cell lung cancer (NSCLC) participants
* Treatment with nivolumab per physician's prescription
Part 2
* Histologically or cytologically confirmed diagnosis of recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN)
* Treatment with nivolumab for recurrent or metastatic SCCHN
Part 3
* Histologically or cytologically confirmed diagnosis of locally advanced/metastatic NSCLC
* Participants with at least one dose of nivolumab administered since June 2018
Part 4
* Histologically or cytologically confirmed diagnosis of recurrent/metastatic SCCHN
* Participants with at least one dose of nivolumab administered since September 2019
Exclusion Criteria
* Current or pending participation in a clinical trial
* Current or pending systemic treatment for cancer other than NSCLC for part 1 and SCCHN for part 2
* Previously treated with immune checkpoint inhibitors for part 3 and part 4
* Participants must not have any other concurrent primary tumor(s) for part 3 and part 4
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Beijing, Beijing Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Countries
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Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA209-8JH
Identifier Type: -
Identifier Source: org_study_id
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