What is the Purpose of this Study?
The purpose of this study is to examine whether the investigational combination of the drugs pembrolizumab and mRNA-4157 work better than pembrolizumab alone to prevent recurrence in high-risk melanoma. The study will also evaluate the drugs’ safety and tolerability, as well as whether mRNA 4157 and pembrolizumab have any effect on the immune system. Pembrolizumab helps the immune system to kill cancer cells. All patients in this study will receive pembrolizumab. mRNA-4157 is a personalized cancer vaccine designed to increase the activity of drugs like pembrolizumab. Giving pembrolizumab and mRNA-4157 together may help the immune system to kill more cancer cells. Participants have about a 1 in 3 chance of receiving pembrolizumab alone and a 2 in 3 chance of receiving combination treatment.
Eligibility
- * Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
- * Complete resection within 13 weeks prior to the first dose of pembrolizumab
- * Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
- * Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
Where can I participate?
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram
More about this Clinical Trial
What is the full name of this clinical trial?
MRNA-4157-P201: A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma