Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
BMS-936558, China, Nivolumab, Non-Small Cell Lung Cancer, Platinum-based chemotherapy, Postmarketing observational study, Squamous Cell Carcinoma of Head and Neck
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to approximately 48 months | Part 3 and Part 4 |
| 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 |
| Distribution of outcomes of irAEs | Up to approximately 48 months | Part 3 and Part 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 treatment patterns of nivolumab for metastatic SCCHN | Up to approximately 48 months | Part 2 |
| 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: Sex | 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 demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI | Up to approximately 48 months | Part 2 |
| 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 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: Smoking 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 clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history | 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 |
| 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 |
| 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 demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption | Up to approximately 48 months | Part 2 |
| 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 | Up to approximately 48 months | Part 1 and 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 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 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 |
| 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: Treatment sequencing | 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 |
Countries
China
Outcome results
None listed