Replimune (Melanoma and Other Skin Cancers)

This study is divided into 3 periods: the screening period, the study drug period, and the follow-up period. If you choose to join this study, we will find out if you are eligible during the screening period. During this period, you will:

• Have a physical exam
• Answer questionnaires
• Have blood draws and give urine samples
• Have a heart scan (ECG)
• Have several images taken of your tumor(s) and organs (photographs and CT/MRI scans)
• Have a small biopsy done of your tumor, unless you have already had one recently

If you are eligible, you will proceed to the study drug period. During this period, you will:

• Get a dose of the study drug alone injected into a tumor during the first week of the period
• Get a dose of the study drug and a dose of nivolumab infused (IV) two weeks later and receive this same drug combination every other week until the 14th week of the period (7 total doses of study drug + nivolumab)
• Get a dose of nivolumab alone after your final dose of the study drug + nivolumab

If you are able to tolerate the treatment during the study drug period, you will continue to receive an infusion of nivolumab every 4 weeks for up to 20 months. You might also be eligible to be treated with the study drug again, which will depend on how your cancer responds to the first round of treatment. The follow-up period will begin 30 days after you got your last dose of the study drug. This period involves visiting our clinic for check-ups 3 times over the course of about 3 months.