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	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
City
Principal Investigator	Dr. Vincent Castonguay
Coordinator	Marilyn Savard 418-525-4444 poste 67703
Status	Recruiting
Activation Date	05-04-2024
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