Study Results
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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COMPLETED
350 participants
OBSERVATIONAL
2017-03-09
2019-03-01
Brief Summary
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It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.
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Detailed Description
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The RIC-Mel network has set up a national database in order to reference the active file of melanoma patients in France. The RIC-Mel database, supported by Nantes University Hospital, had been approved by French authorities (CCTIRS and CNIL). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris). Nowadays, 49 centres located all over the country are participating, with more than 19,000 melanoma patients included in the database. The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group (GCC) of the French Society of Dermatology .
Based on this, BMS and the RIC-Mel network had established a partnership to set up a study in order to estimate the overall survival of melanoma patients treated by Nivolumab during the French ATU program.
Data are collected in the RIC-Mel database by participating centres. Information of centres, follow-up of activity, data reviewing and extractions are realized by the RIC-Mel network. Data analysis is performed by BMS following a developed statistical protocol.
Patients included in the study were patients with unresectable or advanced metastatic melanoma, which received at least one of Nivolumab, dispensed during the French ATU program.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Routine care
This study is an observational one - there is no change to the routine care. Patients received the Nivolumab independently of the study. Only data will be collected during this project.
Eligibility Criteria
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Inclusion Criteria
* Patients included in French nivolumab ATU program,
* Patients treated by at least one perfusion of nivolumab,
* Patients agreed to participate to the study.
Exclusion Criteria
* Patients having initiated Nivolumab after the 31th December 2015,
* Patients disagreed to participate.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Brigitte DRENO, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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AP-HP Hôpital Ambroise Paré
Paris, Boulogne Billancourt, France
CHU de Grenoble
Grenoble, La Tronche, France
Chu Amiens
Amiens, , France
Hopital St andré-CHU DE Bordeaux
Bordeaux, , France
Chu Clermont-Ferrand
Clermont-Ferrand, , France
Chu Dijon
Dijon, , France
CH du Mans
Le Mans, , France
Chru Lille
Lille, , France
Centre Léon Bérard de Lyon
Lyon, , France
Hospices Civils de Lyon: Lyon Sud
Lyon, , France
Hôpitaux de Marseille
Marseille, , France
CHU NICE
Nice, , France
CH de PAU
Pau, , France
CHU de Rouen
Rouen, , France
Chu Toulouse
Toulouse, , France
Ch Valence
Valence, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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RC17_0027
Identifier Type: -
Identifier Source: org_study_id
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