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NCT03504696 Clinical Trial

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

Melanoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03504696
Other study ID # CA209-555
Secondary ID
Status Completed
Phase
First received February 22, 2018
Last updated April 25, 2018
Start date December 20, 2016
Est. completion date February 20, 2018

Study information
Verified date April 2018
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date February 20, 2018
Est. primary completion date February 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-interventional
Non-interventional

Locations
Country Name City State
France Local Institution Nantes Cedex 1

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy Clinical characteristics will be summarized using descriptive statistics. at baseline
Primary 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
Secondary 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
Secondary 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 1 year and 2 years
Secondary 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
Secondary Distribution of treatment patterns Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics. up to 2 years
Secondary 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
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