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.
Study Type
OBSERVATIONAL
Enrollment
3,102
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Incidence rate of nivolumab-related immune-related adverse events (irAEs)
Time frame: Up to approximately 48 months
Severity of nivolumab-related irAEs
Time frame: Up to approximately 48 months
Incidence rate of nivolumab-related adverse events (AEs)
Time frame: Up to approximately 48 months
Severity of nivolumab-related AEs
Time frame: Up to approximately 48 months
Incidence rate of nivolumab-related serious adverse events (SAEs)
Time frame: Up to approximately 48 months
Severity of nivolumab-related SAEs
Time frame: Up to approximately 48 months
Incidence rate of treatment-related adverse events TRAEs
Part 3 and Part 4
Time frame: Up to approximately 48 months
Severity of TRAEs
Part 3 and Part 4
Time frame: Up to approximately 48 months
Management of irAEs
Part 3 and Part 4
Time frame: Up to approximately 48 months
Distribution of outcomes of irAEs
Part 3 and Part 4
Time frame: Up to approximately 48 months
Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs
Time frame: Up to approximately 48 months
Management of CTCAE Grades 2-5 nivolumab-related AEs
Part 1 and Part 2
Time frame: Up to approximately 48 months
Management of CTCAE Grades 2-5 nivolumab-related SAEs
Part 1 and Part 2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 48 months
Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration
Part 1 and Part 3
Time frame: Up to approximately 48 months
Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing
Part 1 and Part 3
Time frame: Up to approximately 48 months
Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation
Part 1 and Part 3
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
Part 1
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex
Part 1
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
Part 1
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height
Part 1
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI
Part 1
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status
Part 1
Time frame: 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
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities
Part 1
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Part 1
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Part 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 48 months
Distribution of treatment patterns of nivolumab for metastatic SCCHN
Part 2
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age
Part 2
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex
Part 2
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight
Part 2
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height
Part 2
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI
Part 2
Time frame: Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption
Part 2
Time frame: 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
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status
Part 2
Time frame: 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
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities
Part 2
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Part 2
Time frame: Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Part 2
Time frame: 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
Time frame: 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
Time frame: Up to approximately 48 months
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