Vessie/urothélial

TITRE	(EN) A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent
PROTOCOLE ID	ARTEMIDE-Biliary01
CLINICAL TRIAL.gov ID	NCT06109779
TYPE(S) DE CANCER	Vessie/urothélial
PHASE	Phase III
TYPE D'ÉTUDE	Clinique
INSTITUTION	CENTRE UNIVERSITAIRE DE SANTE MCGILL 1001 boul. Décarie
VILLE	Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E)	Wassim Kassouf
COORDONATEUR(RICE)	Karla Jauregui Sanchez karla.jaureguisanchez@muhc.mcgill.ca 514-934-1934 poste 34905
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1) Provision of a tumor sample collected at surgical resection. Randomization within 12 weeks after resection with adequate healing and removal of drains. Confirmed to be disease-free by imaging within 28 days prior to randomization. Eastern Cooperative Oncology Group performance status of 0 or 1
CRITÈRES D'EXCLUSION	(EN) Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis. Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors. Any anti-cancer therapy for BTC prior to surgery Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease Current or prior use of immunosuppressive medication within 14 days before the first dose Thromboembolic event within 3 months Active HBV or HCV infection unless treated.