The University of Virginia is participating in a clinical research study for adults ages 18 and over, who had high-risk melanoma skin cancer, but are now melanoma free following surgery. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in participants that have had melanoma removal surgery but are still at high risk for the recurrence of the disease.
The study is looking at several other research questions, including:
• What side effects may happen from receiving the study drugs.
• How much study drug is in your blood at different times.
• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in your blood stream that fight infections.
• How administering the study drugs might improve your quality of life.
• Exploratory research to better understand the study drugs and melanoma.
If you choose to be in this study, your part in the study is expected to last about 5 years.
• Screening phase: about 28 days
• Treatment phase: about 12 months
• Post-treatment phase: about 4 years
If you qualify to participate in this study, you will be randomly assigned (by chance; similar to drawing straws) to receive either fianlimab with cemiplimab or pembrolizumab with placebo. You will have an equal chance of receiving either one of the study drugs dose combinations (i.e., higher dose fianlimab and cemiplimab or lower dose fianlimab and cemiplimab, or pembrolizumab with placebo) listed below.
You will be randomly assigned to any 1 of the 3 treatments listed below.
• Fianlimab 1600 mg (higher dose fianlimab) in combination with cemiplimab 350 mg every 3 weeks
• Fianlimab 400 mg (lower dose fianlimab) in combination with cemiplimab 350 mg every 3 weeks
• Pembrolizumab 200 mg with a placebo every 3 weeks. A placebo looks like a study drug but does not contain any real medicine.
You will be given the doses into a vein using a needle. This is called an IV infusion.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.