Groupe d'Etude en Oncologie du Quebec

Title	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
ClinicalTrials.gov ID	NCT06305767
Cancer Type(s)	Bladder/urothelial
Phase	Phase II
Stage
Study Type	Clinical
Drug	V940 + Pembrolizumab Versus Placebo + Pembrolizumab
Institution	CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE HOPITAL FLEURIMONT 3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
City
Principal Investigator	Dr. Claudio Jeldres
Coordinator	Shawn Byrns-Corbeil 819-346-1110 poste13466
Status	Recruiting
Activation Date	14-05-2024
Eligibility Criteria	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
Exclusion Criteria	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

Groupe d'étude en oncologie du Québec