CTIS2023-505658-17-00招募中1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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