This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.
Study Type
OBSERVATIONAL
Enrollment
400
Non-interventional
Local Institution
Nantes, France
Overall survival (OS) at 1 year
Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program
Time frame: at 1 year
Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program
Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program using descriptive statistics
Time frame: at baseline
Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy
Clinical characteristics will be summarized using descriptive statistics.
Time frame: at baseline
Overall survival (OS) at 2 years
Overall survival (OS) for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the ATU (Temporary Authorization for Use) program
Time frame: at 2 years
Progression-free survival (PFS)
(PFS) will be measured by the time since nivolumab initiation to either the first disease progression date or last known tumor assessment date, or death
Time frame: 1 year and 2 years
Objective response rate (ORR)
ORR is the proportion of patients with an objective response. Objective response is measured by the sum of partial responses plus complete responses as assessed by (RECIST 1.1) Response Evaluation Criteria In Solid Tumors
Time frame: 1 year and 2 years
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Progression-free survival (PFS) as assessed by RECIST 1.1
PFS measured by time since index date (initial treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first as assessed by RECIST 1.1
Time frame: at 1 year
Distribution of treatment patterns
Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics.
Time frame: up to 2 years
Incidence of select Grade 3, 4, or 5 adverse events (AEs)
Select AEs include pulmonary, endocrine, gastrointestinal, hepatic, renal, cutaneous, and infusion reactions
Time frame: up to 2 years