Etude : MS100070_0176 /



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
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : MS100070_0176

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 28/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.


Study arm:
Participants entering this roll over study will receive avelumab (MSB0010718C) as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).


Current primary outcome:
Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events [ Time Frame: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab) ]

Current secondary outcomes:
- Overall Survival (OS) [ Time Frame: From baseline up to 5 years ]
- Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From baseline up to 5 years ]
- Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) [ Time Frame: From baseline up to 5 years ]

Phase : III

Stade : Localement avancé à Métastasique

2, 3, 4
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 under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany, Merck Serono Co., Ltd (Japan)
- Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
- Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
- Other protocol defined inclusion criteria could apply.

Critères de non-inclusion : - Participants who are pregnant or breastfeeding
- Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
- Participant has been enrolled in the comparator arm of avelumab parent study
- Participant has been withdrawn from avelumab parent study for any reason
- Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study
- Other protocol defined exclusion criteria could apply.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03815643
Promoteur :
EMD Serono Research & Development Institute, Inc.
Type de sponsor : Industriel
-
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Professeur Nicolas PENEL

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : CLOS

MAJ : 15/10/2019