Merkel cell carcinoma is a rare skin cancer that begins in Merkel cells, which helps your skin feel touch. IFx-Hu2.0 is a medicine that helps the immune system find and fight cancer. It makes cancer cells show a protein from bacteria, so the immune system knows it is cancer and then destroys it. If you want to join this study, you will first have a visit to see if you qualify. During this visit, you will have tests to check your overall health. This may include a physical exam, a blood draw, a urine test, an ECG, a CT scan, and photos and assessments of your tumor, and a biopsy of your tumor. If you qualify, you will be randomly placed into one of two groups, like flipping a coin. You will not know which group you are in. One group will get IFx-Hu2.0, and the other group will get a placebo. A placebo looks like the study drug but has no active medicine. You will get IFx-Hu2.0 or the placebo as an injection into your tumor once a week for 3 weeks. Both groups will get pembrolizumab as injection once every 3 weeks for the first year, and then once every 6 weeks during the second year. You will have a total of 33 visits. You will have a visit once a week for the first 3 weeks, then a visit once every 3 weeks for the rest of the first year. During the second year, you will have a visit once every 6 weeks. At these visits, you will repeat some of the same tests and procedures that you had at your first visit. Visits will continue unless your cancer gets worse or you have side effects that require you to stop treatment. Your participation in the study may last up to 5 years. You and your insurance will need to pay for your usual medical care. You will not be paid for being in the study, but you may be able to get reimbursed for travel costs.

Who can Participate

You may be able to join this study if you have Stage III or Stage IV Merkel cell carcinoma that has come back or cannot be removed by surgery. You cannot have had checkpoint inhibitors before. This includes drugs like pembrolizumab, avelumab, ipilimumab, nivolumab. You cannot join if you have had chemotherapy that treats your whole body. You cannot take part if you have active cancer in your brain, unless it has already been treated, has stayed stable for at least 4 weeks, and you no longer need steroids. More information about who can and cannot join is on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.

Study ID

More information available at ClinicalTrials.gov: NCT06947928