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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Prospective observation of participants with non-small cell lung cancer (NSCLC) | ||
| Cohort 2 | Prospective observation of participants with squamous cell carcinoma of head and neck (SCCHN) | ||
| Cohort 3 | Retrospective observation of participants with NSCLC | ||
| Cohort 4 | Retrospective observation of participants with SCCHN |
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| 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 |
| 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 |
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Inclusion Criteria:
Part 1
Part 2
Part 3
Part 4
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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In part 1 and part 3, the study population consists of adults with locally advanced or metastatic NSCLC treated with nivolumab per physician's prescription.
In part 2 and 4, the study population consists of adults with recurrent or metastatic SCCHN who are treated with nivolumab per physician's prescription.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100050 | China | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Part 3 and Part 4
| Up to approximately 48 months |
| 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 |
| Shanghai |
| Shanghai Municipality |
| 200120 |
| China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |