Status:
COMPLETED
Post-ATU Study of Nivolumab
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August...
Detailed Description
In order to reach goals of this study, collaboration had been established between BMS and the RIC-Mel network (network for Research and Clinical Investigational Research on Melanoma) (NCT03315468). T...
Eligibility Criteria
Inclusion
- Patients with unresectable or metastatic melanoma cared in participating sites,
- Patients included in French nivolumab ATU program,
- Patients treated by at least one perfusion of nivolumab,
- Patients agreed to participate to the study.
Exclusion
- Patients with unresectable or metastatic melanoma not included in French nivolumab ATU program,
- Patients having initiated Nivolumab after the 31th December 2015,
- Patients disagreed to participate.
Key Trial Info
Start Date :
March 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03325257
Start Date
March 9 2017
End Date
March 1 2019
Last Update
September 14 2021
Active Locations (17)
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1
AP-HP Hôpital Ambroise Paré
Paris, Boulogne Billancourt, France, 992100
2
CHU de Grenoble
Grenoble, La Tronche, France, 38700
3
Chu Amiens
Amiens, France, 80408
4
Hopital St andré-CHU DE Bordeaux
Bordeaux, France, 33000