Brief Summary
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrenceto occur or happen again free survival (RFS) compared to pembrolizumab alone in participants with complete resectionsurgical removal of tissue or part/all of an organ of cutaneous melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) and a high riskthe possibility that something bad will happen of recurrence.
Intervention / Treatment
- Drug: mRNA-4157
- Biological: Pembrolizumab
Key Inclusion Criteria:
- Resectable cutaneous melanoma metastatic to a lymph nodea small lump or mass of tissue in your body and at high risk of recurrence
- Complete resection within 13 weeks prior to the first dosethe amount of medication taken of pembrolizumab
- Disease free at study entry (after surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence) with no loco-regional relapsethe return of disease or distant metastasiswhen the cancer has spread to other parts of the body, also known as mets and no clinical evidence of brain metastases
- Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status 0 or 1
- Normal organ and marrow function reported at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening