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

Study Overview
=================
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 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.

Official Title
-----------------
The Observational Safety Study for Nivolumab in China Routine Oncology Practice

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

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Prospective observation of participants with non-small cell lung cancer (NSCLC) | |
| Cohort 2<br>Prospective observation of participants with squamous cell carcinoma of head and neck (SCCHN) | |
| Cohort 3<br>Retrospective observation of participants with NSCLC | |
| Cohort 4<br>Retrospective observation of participants with SCCHN | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of nivolumab-related immune-related adverse events (irAEs) |  | Up to approximately 48 months | 
| Severity of nivolumab-related irAEs |  | Up to approximately 48 months | 
| Incidence rate of nivolumab-related adverse events (AEs) |  | Up to approximately 48 months | 
| Severity of nivolumab-related AEs |  | Up to approximately 48 months | 
| Incidence rate of nivolumab-related serious adverse events (SAEs) |  | Up to approximately 48 months | 
| Severity of nivolumab-related SAEs |  | Up to approximately 48 months | 
| Incidence rate of treatment-related adverse events TRAEs | Part 3 and Part 4 | Up to approximately 48 months | 
| Severity of TRAEs | Part 3 and Part 4 | Up to approximately 48 months | 
| Management of irAEs | Part 3 and Part 4 | Up to approximately 48 months | 
| Distribution of outcomes of irAEs | Part 3 and Part 4 | Up to approximately 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs |  | Up to approximately 48 months | 
| Management of CTCAE Grades 2-5 nivolumab-related AEs | Part 1 and Part 2 | Up to approximately 48 months | 
| Management of CTCAE Grades 2-5 nivolumab-related SAEs | Part 1 and Part 2 | Up to approximately 48 months | 
| Distribution of outcomes of CTCAE Grades 2-5 irAEs associated with nivolumab when managed according to the risk management algorithms described in the nivolumab label | Part 1 and Part 2 | Up to approximately 48 months | 
| Distribution of outcomes of CTCAE Grades 2-5 AEs associated with nivolumab when managed according to the risk management algorithms described in the nivolumab label | Part 1 and Part 2 | Up to approximately 48 months | 
| Distribution of outcomes of CTCAE Grades 2-5 SAEs associated with nivolumab when managed according to the risk management algorithms described in the nivolumab label | Part 1 and Part 2 | Up to approximately 48 months | 
| Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration | Part 1 and Part 3 | Up to approximately 48 months | 
| Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing | Part 1 and Part 3 | Up to approximately 48 months | 
| Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation | Part 1 and Part 3 | Up to approximately 48 months | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age | Part 1 | Up to approximately 48 months | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex | Part 1 | Up to approximately 48 months | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight | Part 1 | Up to approximately 48 months | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height | Part 1 | Up to approximately 48 months | 
| Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI | Part 1 | Up to approximately 48 months | 
| Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status | Part 1 | Up to approximately 48 months | 
| Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status | Part 1 | Up to approximately 48 months | 
| Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities | Part 1 | Up to approximately 48 months | 
| Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history | Part 1 | Up to approximately 48 months | 
| Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history | Part 1 | Up to approximately 48 months | 
| Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: overall survival (OS) | Part 1 and Part 3 | Up to approximately 48 months | 
| Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: real-world progression free survival (rwPFS) | Part 1 and Part 3 | Up to approximately 48 months | 
| Distribution of treatment patterns of nivolumab for recurrent squamous cell carcinoma of head and neck (SCCHN) | Part 2 and Part 4 | Up to approximately 48 months | 
| Distribution of treatment patterns of nivolumab for metastatic SCCHN | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption | Part 2 | Up to approximately 48 months | 
| Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Human papillomavirus (HPV) status | Part 2 | Up to approximately 48 months | 
| Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status | Part 2 | Up to approximately 48 months | 
| Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status | Part 2 | Up to approximately 48 months | 
| Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities | Part 2 | Up to approximately 48 months | 
| Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history | Part 2 | Up to approximately 48 months | 
| Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history | Part 2 | Up to approximately 48 months | 
| Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: OS | Part 2 and Part 4 | Up to approximately 48 months | 
| Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: rwPFS | Part 2 and Part 4 | Up to approximately 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS-936558, China, Nivolumab, Non-Small Cell Lung Cancer, Platinum-based chemotherapy, Postmarketing observational study, Squamous Cell Carcinoma of Head and Neck