Full Title
A Phase 3, 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 Stage II-IV MelanomaPurpose
Researchers want to see how well a personalized vaccine works for people with melanoma when given with pembrolizumab immunotherapy. The people in this study have melanoma that was removed with surgery and has a high chance of coming back.
The vaccine is called V940 and is an “mRNA vaccine.” It is made in a way similar to the vaccines used to prevent COVID. V940 is made from mRNA taken from a tumor sample collected during surgery to remove melanoma. V940 uses the genes in your tumor to teach your immune system to fight your cancer. It is given as an injection into a muscle.
Pembrolizumab takes the brakes off the immune response, enabling immune cells to find and kill cancer cells. It is given intravenously (by vein).
If you join this study, you will be randomly assigned to get one of these treatments:
- V940 plus pembrolizumab
- Placebo (inactive drug) plus pembrolizumab
Who Can Join
To join this study, there are a few conditions. You must:
- Have stage 2-4 melanoma that was surgically removed within 13 weeks of getting pembrolizumab.
- Have had melanoma that has a high chance of coming back.
- Not have had any anti-cancer medications for melanoma.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information and to see if you can join this study, please call 646-497-9067.