Etude : WAVE / D910FC00001



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : WAVE

Nom : D910FC00001

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 23/04/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information. This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.

Experimental treatment:
Durvalumab: IV infusion q4w with 1500mg durvalumab until progressive disease

Main objective of the trial:
To monitor long-term safety of durvalumab

Secondary objectives of the trial:
-To assess the efficacy of durvalumab in terms of overall response rate (ORR) and duration of response (DOR) in patients who undergo retreatment with durvalumab
-To assess the overall survival (OS) of patients

Phase : IV

Stade : Localisé à Métastatique

NA
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 : - Patient must be 18 years or older, at the time of signing the ICF. For subjects aged < 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
- Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
- Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).
- Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

Critères de non-inclusion : The following exclusion criteria apply only to patients receiving treatment or retreatment:
- Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab
- Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
- Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
- Diagnosis of a new primary malignancy since enrollment into the parent clinical study
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04078152
Promoteur :
AstraZeneca
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Alexis Cortot

TEC / ARC / IDE :
Eric Wasielewski
eric.wasielewski@
chru-lille.fr
03.20.44.56.12

Statut de l'essai : À VENIR

MAJ : 23/04/2020