A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Summary
The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
Timeline
- Start
- 2023-07-19
- Primary completion
- 2029-10-26
- Completion
- 2030-09-26
Outcome
Met primary endpoint
release “在高危黑色素瘤术后辅助治疗的全球Ⅲ期INTerpath-001研究中取得阳性顶线结果。研究共入组1,137名完全切除的IIB-IV期皮肤黑色素瘤患者，在预设中期分析中达到主要终点无复发生存期（RFS）” gritbio.com ↗
release “intismeran autogene (mRNA-4157/V940) plus KEYTRUDA® met the primary endpoint of recurrence-free survival in the Phase 3 INTerpath-001 trial” cancervax.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Intismeran autogene | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |