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

Completed

• Conditions: Melanoma
• Interventions: Other: Non-interventional

• Registration Number: NCT03504696
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12-20
• Primary Completion: 2018-02-20
• Study Completion: 2018-02-20
• Study First Submitted: 2018-02-22
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Advanced Melanoma	Non-interventional	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Local Institution; 🇫🇷 Nantes Cedex 1, France