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OpenTrials
Completed

NCT Number: NCT02847728

Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

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Key information

Conditions

Melanoma Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 1001, Lismore, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18
  • Histologically or cytologically confirmed diagnosis of melanoma (including uveal melanoma) or lung cancer
  • Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent

Exclusion criteria

  • Prior participation in a clinical trial within the past 4 weeks
  • Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
  • Previously treated with anti-CTLA-4 for lung cancer
  • Current or pending participation in a clinical trial
  • Current or pending systemic treatment for cancer other than melanoma and lung cancer
  • Inability to comply with the study protocol

Treatment and study plan

Primary outcomes

  1. Incidence rate of and severity of immune-related pneumonitis - Melanoma

    Time frame: up to nine years

  2. Incidence rate of and severity of immune-related colitis- Melanoma

    Time frame: up to nine years

  3. Incidence rate of and severity of immune-related hepatitis - Melanoma

    Time frame: up to nine years

  4. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma

    Time frame: up to nine years

  5. Incidence rate of and severity of immune-related endocrinopathies - Melanoma

    Time frame: up to nine years

  6. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma

    Time frame: up to nine years

  7. Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma

    Time frame: up to nine years

  8. Incidence rate of and severity of severe infusion reactions- Melanoma

    Time frame: up to nine years

  9. Incidence rate of and severity of immune-related pneumonitis - Lung Cancer

    Time frame: up to nine years

  10. Incidence rate of and severity of immune-related colitis - Lung Cancer

    Time frame: up to nine years

  11. Incidence rate of and severity of immune-related hepatitis - Lung Cancer

    Time frame: up to nine years

  12. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer

    Time frame: up to nine years

  13. Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer

    Time frame: up to nine years

  14. Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer

    Time frame: up to nine years

  15. Incidence rate of and severity of severe infusion reactions - Lung Cancer

    Time frame: up to nine years

  16. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer

    Time frame: up to nine years

Secondary outcomes

  1. Adverse Events

    Time frame: Up to nine years

    Other nivolumab treatment-related AEs

  2. Management of Immune-related AEs:

    Time frame: Up to nine years

  3. Outcomes of Immune-related AEs:

    Time frame: Up to nine years

  4. Overall Survival:

    Time frame: Up to nine years

    1-, 2-, 3-, 4-, and 5-year overall and median survival

  5. Nivolumab treatment pattern

    Time frame: Up to nine years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2016
Registry last updated
Jun 3, 2024

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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