Etude : AdjuMel / CA209-7HU



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : AdjuMel / CA209-7HU

Situation thérapeutique : Adjuvant

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH3

Dernière MÀJ : 12/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude non-interventionnelle, prospective, nationale menée chez des patients atteints d‘un mélanome recevant un traitement adjuvant par nivolumab ainsi que des traitements ultérieurs en cas de rechute

Spécialité : Peau
Localisation : C43 - Mélanome malin de la peau
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.

Current primary outcome:
Relapse-Free Survival (RFS) [ Time Frame: up to 60 months ]

Current secondary outcomes:
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to 60 months ]
- Overall Survival (OS) [ Time Frame: Up to 60 months ]
- Relapse-Free Survival 2 (RFS2) [ Time Frame: Up to 60 months ]
- Progression Free Survival (PFS) [ Time Frame: Up to 60 months ]
- Assessment of health related quality of life [ Time Frame: Up to 60 Months ]
- Assessment of sociodemographic characteristics [ Time Frame: Up to 60 months ]
- Assessment of clinical characteristics [ Time Frame: Up to 60 months ]
- Frequency of nivolumab therapy: number of infusions [ Time Frame: Up to 60 months ]
- Frequency of nivolumab therapy: number of dosing [ Time Frame: Up to 60 months ]
- Frequency of Nivolumab: pattern of use [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: incidence [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: grade [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: type [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs [ Time Frame: Up to 60 months ]
- Describe the use of subsequent therapies after relapse following adjuvant nivolumab [ Time Frame: Up to 60 months ]
- Estimate the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response [ Time Frame: Up to 60 months ]
- Estimate the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate [ Time Frame: Up to 60 months ]
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome [ Time Frame: Up to 60 months ]
- Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS [ Time Frame: Up to 60 months ]
- Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2 [ Time Frame: Up to 60 months ]
- Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: management [ Time Frame: Up to 60 months ]
- Characteristics of nivolumab adjuvant safety profile: outcome [ Time Frame: Up to 60 months ]
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence [ Time Frame: Up to 60 months ]
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type [ Time Frame: Up to 60 months ]
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management [ Time Frame: Up to 60 months ]
- Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome [ Time Frame: Up to 60 months ]

Phase : NA

Stade : Localement avancé à Métastatique

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
- Decision to treat with adjuvant nivolumab therapy has already been taken
- Participants who provide oral informed consent to participate in the study

--- Other protocol defined inclusion/exclusion criteria apply ---

Critères de non-inclusion : - Any participant with a current diagnosis of persisting advanced melanoma
- Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
- Pregnant women
- Person under guardianship

--- Other protocol defined inclusion/exclusion criteria apply ---
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04550247
Promoteur :
BRISTOL MYERS SQUIBB
Type de sponsor : Industriel
BRISTOL MYERS SQUIBB - BRISTOL MYERS SQUIBB
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Dr Anne Bénédicte DUVAL-MODESTE

TEC / ARC / IDE :
Orlane DEBOVES

Statut de l'essai : OUVERT

MAJ : 12/11/2021