Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,189
- Locations
- 94
- Primary Endpoint
- Incidence rate of and severity of immune-related hepatitis - Lung Cancer
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence rate of and severity of immune-related hepatitis - Lung Cancer
Time Frame: up to nine years
Incidence rate of and severity of severe infusion reactions - Lung Cancer
Time Frame: up to nine years
Incidence rate of and severity of immune-related pneumonitis - Melanoma
Time Frame: up to nine years
Incidence rate of and severity of immune-related pneumonitis - Lung Cancer
Time Frame: up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer
Time Frame: up to nine years
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
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma
Time Frame: up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Melanoma
Time Frame: up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma
Time Frame: up to nine years
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
Incidence rate of and severity of immune-related colitis - Lung Cancer
Time Frame: up to nine years
Incidence rate of and severity of immune-related colitis- Melanoma
Time Frame: up to nine years
Incidence rate of and severity of immune-related hepatitis - Melanoma
Time Frame: up to nine years
Incidence rate of and severity of severe infusion reactions- Melanoma
Time Frame: up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer
Time Frame: up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer
Time Frame: up to nine years
Secondary Outcomes
- Adverse Events(Up to nine years)
- Outcomes of Immune-related AEs:(Up to nine years)
- Management of Immune-related AEs:(Up to nine years)
- Overall Survival:(Up to nine years)
- Nivolumab treatment pattern(Up to nine years)