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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Advanced Melanoma | RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | at baseline |
| Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy | Clinical characteristics will be summarized using descriptive statistics. | 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 | at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year and 2 years |
| Objective response rate (ORR) |
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Inclusion Criteria:
Patients included in RIC-Mel Database:
Patients included in French nivolumab ATU program
Exclusion Criteria:
• Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial
Other protocol defined inclusion/exclusion criteria could apply
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RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nantes | 44093 | France |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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
| 1 year and 2 years |
| 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 | at 1 year |
| Distribution of treatment patterns | Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics. | 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 | up to 2 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |