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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Squamous Cell Carcinoma of Head and Neck; Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04825873

CA209-8JH

Details and patient eligibility

About

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.

Enrollment: 3,102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,102 participants in 4 patient groups

Cohort 1

Description:

Prospective observation of participants with non-small cell lung cancer (NSCLC)

Cohort 2

Description:

Prospective observation of participants with squamous cell carcinoma of head and neck (SCCHN)

Cohort 3

Description:

Retrospective observation of participants with NSCLC

Cohort 4

Description:

Retrospective observation of participants with SCCHN