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

Study Overview
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Brief Summary
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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.

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

Conditions
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Melanoma, Lung Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm Design<br>The study encompasses a single arm design with 417 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 772 adults treated with nivolumab for histologically or cytologically confirmed lung cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of and severity of immune-related pneumonitis - Melanoma |  | up to nine years | 
| Incidence rate of and severity of immune-related colitis- Melanoma |  | up to nine years | 
| Incidence rate of and severity of immune-related hepatitis - Melanoma |  | up to nine years | 
| Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma |  | up to nine years | 
| Incidence rate of and severity of immune-related endocrinopathies - Melanoma |  | up to nine years | 
| Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma |  | 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 |  | up to nine years | 
| Incidence rate of and severity of severe infusion reactions- Melanoma |  | up to nine years | 
| Incidence rate of and severity of immune-related pneumonitis - Lung Cancer |  | up to nine years | 
| Incidence rate of and severity of immune-related colitis - Lung Cancer |  | up to nine years | 
| Incidence rate of and severity of immune-related hepatitis - Lung Cancer |  | up to nine years | 
| Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer |  | up to nine years | 
| Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer |  | 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 |  | up to nine years | 
| Incidence rate of and severity of severe infusion reactions - Lung Cancer |  | up to nine years | 
| Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer |  | up to nine years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Other nivolumab treatment-related AEs | Up to nine years | 
| Management of Immune-related AEs: |  | Up to nine years | 
| Outcomes of Immune-related AEs: |  | Up to nine years | 
| Overall Survival: | 1-, 2-, 3-, 4-, and 5-year overall and median survival | Up to nine years | 
| Nivolumab treatment pattern |  | Up to nine years |