Melanoma
Conditions
Brief summary
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.
Interventions
OTHERNon-interventional
Non-interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients included in RIC-Mel Database: * Diagnosed with melanoma and cared for in the participating sites * Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out * 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) at 1 year | 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 |
| Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program | at baseline | Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program using descriptive statistics |
| Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy | at baseline | Clinical characteristics will be summarized using descriptive statistics. |
| Overall survival (OS) at 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 1 year and 2 years | (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 |
| Incidence of select Grade 3, 4, or 5 adverse events (AEs) | up to 2 years | Select AEs include pulmonary, endocrine, gastrointestinal, hepatic, renal, cutaneous, and infusion reactions |
| Objective response rate (ORR) | 1 year and 2 years | 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 |
| Progression-free survival (PFS) as assessed by RECIST 1.1 | at 1 year | 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 |
| Distribution of treatment patterns | up to 2 years | Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics. |
Countries
France
Outcome results
None listed