Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced Melanoma

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03504696

CA209-555

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Patients with Advanced Melanoma

Description:

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)

Treatment:

Other: Non-interventional