Etude : WITNESS / CA209-9GY



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 : WITNESS / CA209-9GY

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Immunothérapie

Cadre réglementaire : RIPH3

Dernière MÀJ : 10/06/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) With or Without Ipilimumab (BMS-734016) in Patients With Advanced Renal Cell Carcinoma in Real Life Setting

Spécialité : Voies urinaires
Localisation : C64 - Tumeur maligne du rein, à l'exception du bassinet
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.


- Cohort 1: Nivolumab ---FERMEE AUX INCLUSIONS---
Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC

- Cohort 2: Nivolumab + Ipilimumab
Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC


Current primary outcome:
Overall Survival (OS) [ Time Frame: Up to 3 years ]

Current secondary outcomes:
- Overall Survival (OS) [ Time Frame: Up to 3 years ]
- Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
- Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
- Best Overall Response Rate (BORR) [ Time Frame: Up to 3 years ]
- Best Overall Response (BOR) [ Time Frame: Up to 3 years ]
- Distribution of socio-demographic characteristics of participants [ Time Frame: Approximately 3 years ]
- Distribution of clinical characteristics of participants [ Time Frame: Approximately 3 years ]
- Distribution of management of participants with treatment-related adverse events (AEs) [ Time Frame: Approximately 3 years ]
- Distribution of management of participants according to Memorial Sloan Kettering Cancer Center (MSKCC) score [ Time Frame: At baseline ]
- Distribution of management of participants according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score [ Time Frame: At baseline ]
- Distribution of treatment patterns in participants with advanced Renal Cell Carcinoma (RCC) [ Time Frame: Approximately 3 years ]
- Distribution of incidence of AEs [ Time Frame: Approximately 3 years ]
- Distribution of Severity of AEs [ Time Frame: Approximately 3 years ]
- Distribution of management of AEs [ Time Frame: Approximately 3 years ]
- Health-related quality of life of participants using Functional Assessment of Cancer Therapy -Kidney Symptom Index (FKSI-19) questionnaires [ Time Frame: Approximately 3 years ]
- Health-related quality of life of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires [ Time Frame: Approximately 3 years ]

Phase : NA

Stade : Localement avancé à Métastatique

1, 2, 3
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 : ---Liste non exhaustive---

- Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France

NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC

Critères de non-inclusion : ---Liste non exhaustive---

- Primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
- Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy
- Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled
- Pregnant women and participants under guardianship
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03455452
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 :
Insititut Andrée DUTREIX - 891 avenue de Rosendaël - 59240 DUNKERQUE

Investigateur :
Docteur Jean-Philippe WAGNER

TEC / ARC / IDE :
Florence HENNETIER
fhennetier@
iadonco.org
03 28 51 96 30

Statut de l'essai : CLOS

MAJ : 04/03/2020

Centre investigateur :
Centre Pierre Curie - 1 rue Delbecque - 62660 BEUVRY

Investigateur :
Docteur Aurélie FADIN

TEC / ARC / IDE :
Laetitia GALLOIS
laetitia.gallois@
ichf.fr
03 21 61 92 70 - Poste : 6654

Statut de l'essai : CLOS

MAJ : 04/03/2020

Centre investigateur :
Centre Hospitalier de Lens - 99 Route de la Bassée - 62300 LENS

Investigateur :
Docteur Fabienne WATELLE

TEC / ARC / IDE :
Quentin DHALLUIN
quentin.dhalluin@
chru-lille.fr
06.03.64.80.47

Statut de l'essai : CLOS

MAJ : 24/01/2020

Centre investigateur :
Clinique de Flandre - 300 rue des Forts - 59210 COUDEKERQUE BRANCHE

Investigateur :
Docteur Jean-Philippe WAGNER

TEC / ARC / IDE :
Florence HENNETIER
fhennetier@
iadonco.org
03 28 51 96 30

Statut de l'essai : OUVERT

MAJ : 10/06/2021

Centre investigateur :
Centre de cancérologie Les Dentellières - 8-10 Avenue Vauban - 59300 VALENCIENNES

Investigateur :
Docteur Jessica GROSJEAN

TEC / ARC / IDE :
Stéphanie VERMOESEN / Morgane HOULZE
svermoesen@
lesdentellieres.com
03 66 22 72 66

Statut de l'essai : OUVERT

MAJ : 08/06/2021