Etude : POD1UM-202 / PODIUM 202 - INCMGA 0012-202



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 : POD1UM-202

Nom : PODIUM 202 - INCMGA 0012-202

Traitement : Adjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 04/12/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy

Spécialité : Organes digestifs
Localisation : C21 - Tumeur maligne de l'anus et du canal anal
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Ability to comprehend and willingness to sign a written informed consent form.
Confirmed diagnosis of locally advanced or metastatic SCAC.
Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
Must have measurable disease by RECIST v1.1.
Eastern Cooperative Oncology Group performance status of 0 to 1.
If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

Phase : II

Stade : Localement avancé à Métastasique

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 : Ability to comprehend and willingness to sign a written informed consent form.
Confirmed diagnosis of locally advanced or metastatic SCAC.
Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
Must have measurable disease by RECIST v1.1.
Eastern Cooperative Oncology Group performance status of 0 to 1.
If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

Critères de non-inclusion : Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is > 30 Gy.
Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
Active autoimmune disease requiring systemic immunosuppression.
Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
Known active hepatitis infection.
Active infections requiring systemic therapy.
Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03597295
Promoteur :
Incyte Corporation
Type de sponsor : Industriel
1801 Augustine Cut-off Wilmington, DE 19803
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 :

TEC / ARC / IDE :
Patricia FOSSE
patricia.fosse@
chu-rouen.fr
02 32 88 86 10 poste 64 462

Ouverture de l'essai : CLOS

MAJ : 04/12/2019