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

October 11, 2023 updated by: Bristol-Myers Squibb

The Observational Safety Study for Nivolumab in China Routine Oncology Practice

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of nivolumab-related immune-related adverse events (irAEs)
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Severity of nivolumab-related irAEs
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Incidence rate of nivolumab-related adverse events (AEs)
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Severity of nivolumab-related AEs
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Incidence rate of nivolumab-related serious adverse events (SAEs)
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Severity of nivolumab-related SAEs
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Incidence rate of treatment-related adverse events TRAEs
Time Frame: Up to approximately 48 months
Part 3 and Part 4
Up to approximately 48 months
Severity of TRAEs
Time Frame: Up to approximately 48 months
Part 3 and Part 4
Up to approximately 48 months
Management of irAEs
Time Frame: Up to approximately 48 months
Part 3 and Part 4
Up to approximately 48 months
Distribution of outcomes of irAEs
Time Frame: Up to approximately 48 months
Part 3 and Part 4
Up to approximately 48 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs
Time Frame: Up to approximately 48 months
Up to approximately 48 months
Management of CTCAE Grades 2-5 nivolumab-related AEs
Time Frame: Up to approximately 48 months
Part 1 and Part 2
Up to approximately 48 months
Management of CTCAE Grades 2-5 nivolumab-related SAEs
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
Part 1 and Part 2
Up to approximately 48 months
Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration
Time Frame: Up to approximately 48 months
Part 1 and Part 3
Up to approximately 48 months
Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing
Time Frame: Up to approximately 48 months
Part 1 and Part 3
Up to approximately 48 months
Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Time Frame: Up to approximately 48 months
Part 1
Up to approximately 48 months
Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Time Frame: Up to approximately 48 months
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)
Time Frame: Up to approximately 48 months
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)
Time Frame: Up to approximately 48 months
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)
Time Frame: Up to approximately 48 months
Part 2 and Part 4
Up to approximately 48 months
Distribution of treatment patterns of nivolumab for metastatic SCCHN
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
Time Frame: Up to approximately 48 months
Part 2
Up to approximately 48 months
Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: OS
Time Frame: Up to approximately 48 months
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
Time Frame: Up to approximately 48 months
Part 2 and Part 4
Up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-8JH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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