A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China

The Observational Safety Study for Nivolumab in China Routine Oncology Practice

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 with platinum-based chemotherapy that has locally advanced or has spread. Part two will investigate nivolumab for post-platinum squamous cell carcinoma of head and neck that is recurrent or has spread. Part three will investigate nivolumab for locally advanced or metastatic non-small cell lung cancer. Part four will investigate nivolumab for recurrent or metastatic squamous cell carcinoma of head and neck.

Inclusion Criteria:

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 Criteria:

• 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