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 - V940-005

Merck Sharp & Dohme LLC0 sites220 target enrollmentNovember 13, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 220
Status: Recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

November 13, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 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 (MK\-3475\) 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, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization