Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Overall survival (OS) at 1 year
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/exclusion criteria could apply
Outcomes
Primary Outcomes
Overall survival (OS) at 1 year
Time Frame: 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
Time Frame: 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
Time Frame: at baseline
Clinical characteristics will be summarized using descriptive statistics.
Overall survival (OS) at 2 years
Time Frame: 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 Outcomes
- Incidence of select Grade 3, 4, or 5 adverse events (AEs)(up to 2 years)
- Progression-free survival (PFS)(1 year and 2 years)
- Objective response rate (ORR)(1 year and 2 years)
- Progression-free survival (PFS) as assessed by RECIST 1.1(at 1 year)
- Distribution of treatment patterns(up to 2 years)