Status:
COMPLETED
A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Non-Small Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the safety of nivolumab in routine cancer practice in China. Part one of the study will investigate nivolumab for non-small cell lung cancer previously treated w...
Eligibility Criteria
Inclusion
- Part 1
- 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
- Prior participation in a clinical trial within the past 4 weeks
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
May 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 13 2023
Estimated Enrollment :
3102 Patients enrolled
Trial Details
Trial ID
NCT04825873
Start Date
May 28 2021
End Date
February 13 2023
Last Update
October 13 2023
Active Locations (2)
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1
Local Institution
Beijing, Beijing Municipality, China, 100050
2
Local Institution
Shanghai, Shanghai Municipality, China, 200120