Phase 2 Study of Adjuvant V940 and Pembrolizumab in Muscle-invasive Urothelial Carcinoma
- Conditions
- High-risk Muscle-invasive Urothelial Carcinoma Post-radical ResectionMedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505658-17-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method