Clinical trial NCT03325257: Post-ATU Study of Nivolumab
Official title: Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Unresectable melanoma
metastatic melanoma
Immunotherapy
Nivolumab
Temporary Auhorization for Use (ATU)
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-10-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

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.

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Overall Survival of patients included in the study thanks to subgroups of interest
timeFrame: 2 years
Secondary outcomes:
measure: Distribution of melanoma patients included in the study in all subgroups of interest thanks to their clinical features at the time of treatment initiation
timeFrame: Day 1
measure: Proportion of melanoma patients included in the study categorized by genders overall and by subgroups of interest
timeFrame: Day 1
measure: Distribution of age of melanoma patients included in the study overall and by subgroups of interest
timeFrame: Day 1
measure: Description of Nivolumab treatment of melanoma patients included in the study
timeFrame: 2 years
measure: Incidence of select grade 3, 4 and 5 adverse events (AE) in melanoma patients included in the study and related to Nivolumab treatment
timeFrame: 2 years
measure: Progression-free survival of melanoma patients included in the study
timeFrame: 2 years
measure: Objective response rate of melanoma patients included in the study
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Hôpital Ambroise Paré
state: Boulogne Billancourt
city: Grenoble
country: France
facility: CHU de Grenoble
state: La Tronche
city: Amiens
country: France
facility: Chu Amiens
city: Bordeaux
country: France
facility: Hopital St andré-CHU DE Bordeaux
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Dijon
country: France
facility: Chu Dijon
city: Le Mans
country: France
facility: CH du Mans
city: Lille
country: France
facility: Chru Lille
city: Lyon
country: France
facility: Centre Léon Bérard de Lyon
city: Lyon
country: France
facility: Hospices Civils de Lyon: Lyon Sud
city: Marseille
country: France
facility: Hôpitaux de Marseille
city: Nice
country: France
facility: CHU NICE
city: Pau
country: France
facility: CH de PAU
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: Chu Toulouse
city: Valence
country: France
facility: Ch Valence
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Nantes University Hospital
name: Brigitte DRENO, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: