Overview
The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.
Eligibility
Inclusion 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