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Non-Small Cell Lung CancerNCT04825873

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

An observational study of Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of Head and Neck, run by Bristol-Myers Squibb at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,102 participants
Where
2 sitesChina
Study dates
28 May 2021to 13 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Local Institution

    Beijing, Beijing Municipality, 100050

  • Local Institution

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: 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.

Keywords
BMS-936558, China, Nivolumab, Non-Small Cell Lung Cancer, Platinum-based chemotherapy, Postmarketing observational study, Squamous Cell Carcinoma of Head and Neck
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04825873
Study groupRoleWhat they receive
Cohort 1Prospective observation of participants with non-small cell lung cancer (NSCLC)
Cohort 2Prospective observation of participants with squamous cell carcinoma of head and neck (SCCHN)
Cohort 3Retrospective observation of participants with NSCLC
Cohort 4Retrospective observation of participants with SCCHN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of nivolumab-related immune-related adverse events (irAEs)

    Measured: Up to approximately 48 months

  2. Severity of nivolumab-related irAEs

    Measured: Up to approximately 48 months

  3. Incidence rate of nivolumab-related adverse events (AEs)

    Measured: Up to approximately 48 months

  4. Severity of nivolumab-related AEs

    Measured: Up to approximately 48 months

  5. Incidence rate of nivolumab-related serious adverse events (SAEs)

    Measured: Up to approximately 48 months

  6. Severity of nivolumab-related SAEs

    Measured: Up to approximately 48 months

  7. Incidence rate of treatment-related adverse events TRAEs

    Part 3 and Part 4

    Measured: Up to approximately 48 months

  8. Severity of TRAEs

    Part 3 and Part 4

    Measured: Up to approximately 48 months

  9. Management of irAEs

    Part 3 and Part 4

    Measured: Up to approximately 48 months

  10. Distribution of outcomes of irAEs

    Part 3 and Part 4

    Measured: Up to approximately 48 months

Secondary outcomes (37)

  1. Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs

    Measured: Up to approximately 48 months

  2. Management of CTCAE Grades 2-5 nivolumab-related AEs

    Part 1 and Part 2

    Measured: Up to approximately 48 months

  3. Management of CTCAE Grades 2-5 nivolumab-related SAEs

    Part 1 and Part 2

    Measured: Up to approximately 48 months

  4. 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

    Measured: Up to approximately 48 months

  5. 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

    Measured: Up to approximately 48 months

  6. 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

    Measured: Up to approximately 48 months

  7. Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration

    Part 1 and Part 3

    Measured: Up to approximately 48 months

  8. Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing

    Part 1 and Part 3

    Measured: Up to approximately 48 months

  9. Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation

    Part 1 and Part 3

    Measured: Up to approximately 48 months

  10. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age

    Part 1

    Measured: Up to approximately 48 months

  11. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex

    Part 1

    Measured: Up to approximately 48 months

  12. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight

    Part 1

    Measured: Up to approximately 48 months

  13. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height

    Part 1

    Measured: Up to approximately 48 months

  14. Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI

    Part 1

    Measured: Up to approximately 48 months

  15. Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status

    Part 1

    Measured: Up to approximately 48 months

  16. Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status

    Part 1

    Measured: Up to approximately 48 months

  17. Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities

    Part 1

    Measured: Up to approximately 48 months

  18. Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history

    Part 1

    Measured: Up to approximately 48 months

  19. Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history

    Part 1

    Measured: Up to approximately 48 months

  20. Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: overall survival (OS)

    Part 1 and Part 3

    Measured: Up to approximately 48 months

  21. 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

    Measured: Up to approximately 48 months

  22. Distribution of treatment patterns of nivolumab for recurrent squamous cell carcinoma of head and neck (SCCHN)

    Part 2 and Part 4

    Measured: Up to approximately 48 months

  23. Distribution of treatment patterns of nivolumab for metastatic SCCHN

    Part 2

    Measured: Up to approximately 48 months

  24. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age

    Part 2

    Measured: Up to approximately 48 months

  25. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex

    Part 2

    Measured: Up to approximately 48 months

  26. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight

    Part 2

    Measured: Up to approximately 48 months

  27. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height

    Part 2

    Measured: Up to approximately 48 months

  28. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI

    Part 2

    Measured: Up to approximately 48 months

  29. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption

    Part 2

    Measured: Up to approximately 48 months

  30. Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Human papillomavirus (HPV) status

    Part 2

    Measured: Up to approximately 48 months

  31. Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status

    Part 2

    Measured: Up to approximately 48 months

  32. Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status

    Part 2

    Measured: Up to approximately 48 months

  33. Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities

    Part 2

    Measured: Up to approximately 48 months

  34. Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history

    Part 2

    Measured: Up to approximately 48 months

  35. Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history

    Part 2

    Measured: Up to approximately 48 months

  36. Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: OS

    Part 2 and Part 4

    Measured: Up to approximately 48 months

  37. Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: rwPFS

    Part 2 and Part 4

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start28 May 2021
  3. Primary completion13 Feb 2023
  4. Study completion13 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04825873
Sponsor's protocol ID
CA209-8JH
Status last verified
Oct 2023
First submitted
30 Mar 2021
Last updated
13 Oct 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of Head and Neck, run by Bristol-Myers Squibb at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of nivolumab-related immune-related adverse events (irAEs) (time frame: Up to approximately 48 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04825873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.

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