A Study to Assess Safety of Nivolumab in Routine Oncology Practice in China

Non-Small Cell Lung Cancer Clinical Trial

Official title:

The Observational Safety Study for Nivolumab in China Routine Oncology Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825873
• Other study ID #: CA209-8JH
• Status: Completed
• Start date: May 28, 2021
• Est. completion date: February 13, 2023

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3102
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Non-Small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

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

External Links

•   BMS Clinical Trial Information