Clinical trial NCT04825873: A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China
Official title: The Observational Safety Study for Nivolumab in China Routine Oncology Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
Keywords: BMS-936558
China
Nivolumab
Non-Small Cell Lung Cancer
Platinum-based chemotherapy
Postmarketing observational study
Squamous Cell Carcinoma of Head and Neck
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 3102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Incidence rate of nivolumab-related immune-related adverse events (irAEs)
timeFrame: Up to approximately 48 months
measure: Severity of nivolumab-related irAEs
timeFrame: Up to approximately 48 months
measure: Incidence rate of nivolumab-related adverse events (AEs)
timeFrame: Up to approximately 48 months
measure: Severity of nivolumab-related AEs
timeFrame: Up to approximately 48 months
measure: Incidence rate of nivolumab-related serious adverse events (SAEs)
timeFrame: Up to approximately 48 months
measure: Severity of nivolumab-related SAEs
timeFrame: Up to approximately 48 months
measure: Incidence rate of treatment-related adverse events TRAEs
timeFrame: Up to approximately 48 months
measure: Severity of TRAEs
timeFrame: Up to approximately 48 months
measure: Management of irAEs
timeFrame: Up to approximately 48 months
measure: Distribution of outcomes of irAEs
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs
timeFrame: Up to approximately 48 months
measure: Management of CTCAE Grades 2-5 nivolumab-related AEs
timeFrame: Up to approximately 48 months
measure: Management of CTCAE Grades 2-5 nivolumab-related SAEs
timeFrame: Up to approximately 48 months
measure: 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
timeFrame: Up to approximately 48 months
measure: 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
timeFrame: Up to approximately 48 months
measure: 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
timeFrame: Up to approximately 48 months
measure: Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration
timeFrame: Up to approximately 48 months
measure: Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing
timeFrame: Up to approximately 48 months
measure: Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
timeFrame: Up to approximately 48 months
measure: Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: overall survival (OS)
timeFrame: Up to approximately 48 months
measure: Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: real-world progression free survival (rwPFS)
timeFrame: Up to approximately 48 months
measure: Distribution of treatment patterns of nivolumab for recurrent squamous cell carcinoma of head and neck (SCCHN)
timeFrame: Up to approximately 48 months
measure: Distribution of treatment patterns of nivolumab for metastatic SCCHN
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption
timeFrame: Up to approximately 48 months
measure: Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Human papillomavirus (HPV) status
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history
timeFrame: Up to approximately 48 months
measure: Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
timeFrame: Up to approximately 48 months
measure: Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: OS
timeFrame: Up to approximately 48 months
measure: Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: rwPFS
timeFrame: Up to approximately 48 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: