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OpenTrials
Completed

NCT Number: NCT04825873

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Up to approximately 48 months

  2. Severity of nivolumab-related irAEs

    Time frame: Up to approximately 48 months

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

    Time frame: Up to approximately 48 months

  4. Severity of nivolumab-related AEs

    Time frame: Up to approximately 48 months

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

    Time frame: Up to approximately 48 months

  6. Severity of nivolumab-related SAEs

    Time frame: Up to approximately 48 months

  7. Incidence rate of treatment-related adverse events TRAEs

    Time frame: Up to approximately 48 months

    Part 3 and Part 4

  8. Severity of TRAEs

    Time frame: Up to approximately 48 months

    Part 3 and Part 4

  9. Management of irAEs

    Time frame: Up to approximately 48 months

    Part 3 and Part 4

  10. Distribution of outcomes of irAEs

    Time frame: Up to approximately 48 months

    Part 3 and Part 4

Secondary outcomes

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

    Time frame: Up to approximately 48 months

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

    Time frame: Up to approximately 48 months

    Part 1 and Part 2

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

    Time frame: Up to approximately 48 months

    Part 1 and Part 2

  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

    Time frame: Up to approximately 48 months

    Part 1 and Part 2

  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

    Time frame: Up to approximately 48 months

    Part 1 and Part 2

  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

    Time frame: Up to approximately 48 months

    Part 1 and Part 2

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

    Time frame: Up to approximately 48 months

    Part 1 and Part 3

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

    Time frame: Up to approximately 48 months

    Part 1 and Part 3

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. Distribution of treatment patterns of nivolumab for metastatic SCCHN

    Time frame: Up to approximately 48 months

    Part 2

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

The Observational Safety Study for Nivolumab in China Routine Oncology Practice

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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