Titre 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
Type(s) de cancer Vessie/urothélial
Phase Phase II
Type étude Clinique
Médicament 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
Ville Sherbrooke
Investigateur(trice) principal(e) Dr Claudio Jeldres
Coordonnateur(trice) Shawn Byrns-Corbeil
 819-346-1110 poste13466
Statut Actif en recrutement
Date d'activation 14-05-2024
Critètes d'éligibilité
  • 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
Critètes d'exclusion
  • 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