Vessie/urothélial

TITRE	(EN) A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
PROTOCOLE ID	V940-005
CLINICAL TRIAL.gov ID	NCT06305767
TYPE(S) DE CANCER	Vessie/urothélial
PHASE	Phase II
TYPE D'ÉTUDE	Clinique
INSTITUTION	CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE 3001 12e Avenue Nord (819) 346-1110
VILLE	Sherbrooke
INVESTIGATEUR(RICE) PRINCIPAL(E)	Claudio Jeldres
COORDONATEUR(RICE)	Shawn Byrns-Corbeil 819-346-1110 poste13466
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) Has muscle-invasive urothelial carcinoma (MIUC) Has dominant histology of UC Has high-risk pathologic disease after radical resection Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS) Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
CRITÈRES D'EXCLUSION	(EN) Has received prior systemic anticancer therapy Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients Has current pneumonitis/interstitial lung disease Has active infection requiring systemic therapy Has active hepatitis B and hepatitis C virus infection