A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China
Completed
- Conditions
- Non-Small Cell Lung CancerSquamous Cell Carcinoma of Head and Neck
- Registration Number
- NCT04825873
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3102
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of TRAEs Up to approximately 48 months Part 3 and Part 4
Management of irAEs Up to approximately 48 months Part 3 and Part 4
Severity of nivolumab-related AEs Up to approximately 48 months Incidence rate of nivolumab-related immune-related adverse events (irAEs) Up to approximately 48 months Incidence rate of nivolumab-related adverse events (AEs) Up to approximately 48 months Incidence rate of nivolumab-related serious adverse events (SAEs) Up to approximately 48 months Severity of nivolumab-related irAEs Up to approximately 48 months Incidence rate of treatment-related adverse events TRAEs Up to approximately 48 months Part 3 and Part 4
Distribution of outcomes of irAEs Up to approximately 48 months Part 3 and Part 4
Severity of nivolumab-related SAEs Up to approximately 48 months
- Secondary Outcome Measures
Name Time Method Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing Up to approximately 48 months Part 1 and Part 3
Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs 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 Up to approximately 48 months Part 1 and Part 2
Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration Up to approximately 48 months Part 1 and Part 3
Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation Up to approximately 48 months Part 1 and Part 3
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height Up to approximately 48 months Part 1
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI Up to approximately 48 months Part 1
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status Up to approximately 48 months Part 1
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history Up to approximately 48 months Part 2
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex Up to approximately 48 months Part 1
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight Up to approximately 48 months Part 1
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status Up to approximately 48 months Part 1
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities Up to approximately 48 months Part 1
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history Up to approximately 48 months Part 1
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history Up to approximately 48 months Part 1
Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: overall survival (OS) Up to approximately 48 months Part 1 and Part 3
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age Up to approximately 48 months Part 2
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight Up to approximately 48 months Part 2
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height Up to approximately 48 months Part 2
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history Up to approximately 48 months Part 2
Management of CTCAE Grades 2-5 nivolumab-related SAEs Up to approximately 48 months Part 1 and Part 2
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 Up to approximately 48 months Part 1 and Part 2
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 Up to approximately 48 months Part 1 and Part 2
Management of CTCAE Grades 2-5 nivolumab-related AEs Up to approximately 48 months Part 1 and Part 2
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age Up to approximately 48 months Part 1
Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: real-world progression free survival (rwPFS) Up to approximately 48 months Part 1 and Part 3
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption Up to approximately 48 months Part 2
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Human papillomavirus (HPV) status Up to approximately 48 months Part 2
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status Up to approximately 48 months Part 2
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities Up to approximately 48 months Part 2
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex Up to approximately 48 months Part 2
Distribution of treatment patterns of nivolumab for metastatic SCCHN Up to approximately 48 months Part 2
Distribution of treatment patterns of nivolumab for recurrent squamous cell carcinoma of head and neck (SCCHN) Up to approximately 48 months Part 2 and Part 4
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI Up to approximately 48 months Part 2
Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: rwPFS Up to approximately 48 months Part 2 and Part 4
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status Up to approximately 48 months Part 2
Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: OS Up to approximately 48 months Part 2 and Part 4
Trial Locations
- Locations (1)
Local Institution
🇨🇳Shanghai, Shanghai, China