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

NCT ID: NCT03504696

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-20

Study Completion Date

2018-02-20

Brief Summary

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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

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with Advanced Melanoma

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)

Non-interventional

Intervention Type OTHER

Non-interventional

Interventions

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Non-interventional

Non-interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Nantes, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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CA209-555

Identifier Type: -

Identifier Source: org_study_id

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