Post-ATU Study of Nivolumab
Post-ATU
Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program
1 other identifier
observational
350
1 country
17
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 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2017
CompletedFirst Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedSeptember 14, 2021
September 1, 2021
1.5 years
July 13, 2017
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival of patients included in the study thanks to subgroups of interest
Overall survival is defined as the time from index date (initiation of Nivolumab) until date of death due to any cause. Overall survival will be censored on the last date a subject was known to be alive. Estimates of survival rates will be realized for 1-year and 2-year survival. Median time will also be calculated. Subgroups of interest are described in the description of the first Secondary Outcome Measure. Safety Issue: No
2 years
Secondary Outcomes (7)
Distribution of melanoma patients included in the study in all subgroups of interest thanks to their clinical features at the time of treatment initiation
Day 1
Proportion of melanoma patients included in the study categorized by genders overall and by subgroups of interest
Day 1
Distribution of age of melanoma patients included in the study overall and by subgroups of interest
Day 1
Description of Nivolumab treatment of melanoma patients included in the study
2 years
Incidence of select grade 3, 4 and 5 adverse events (AE) in melanoma patients included in the study and related to Nivolumab treatment
2 years
- +2 more secondary outcomes
Interventions
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
patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- Bristol-Myers Squibbcollaborator
Study Sites (17)
AP-HP Hôpital Ambroise Paré
Paris, Boulogne Billancourt, 992100, France
CHU de Grenoble
Grenoble, La Tronche, 38700, France
Chu Amiens
Amiens, 80408, France
Hopital St andré-CHU DE Bordeaux
Bordeaux, 33000, France
Chu Clermont-Ferrand
Clermont-Ferrand, 63000, France
Chu Dijon
Dijon, 21000, France
CH du Mans
Le Mans, 72000, France
Chru Lille
Lille, 59000, France
Centre Léon Bérard de Lyon
Lyon, 69008, France
Hospices Civils de Lyon: Lyon Sud
Lyon, 69229, France
Hôpitaux de Marseille
Marseille, 13000, France
CHU NICE
Nice, 06000, France
CH de PAU
Pau, 64000, France
CHU de Rouen
Rouen, 76038, France
Chu Toulouse
Toulouse, 31000, France
Ch Valence
Valence, 26000, France
Institut Gustave Roussy
Villejuif, 94800, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigitte DRENO, PU-PH
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
October 30, 2017
Study Start
March 9, 2017
Primary Completion
September 6, 2018
Study Completion
March 1, 2019
Last Updated
September 14, 2021
Record last verified: 2021-09