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.
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
Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel, Navid Hafez, Omid Hamid, Rodolfo Gutierrez