The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have advanced melanoma that is still considered resectable by surgery. This study is being done to answer the following question:
Will treatment before surgery with either pembrolizumab alone, or pembrolizumab combined with CMP-001, cause your melanoma to shrink enough that no more living tumor cells are evident at the time of surgery. This study will also try to answer whether these forms of immunotherapy can affect the chances of the melanoma returning (“relapse risk”) and the chances of death from melanoma (“survival”).
If you decide to take part in this study, you will be randomized to receive either pembrolizumab alone (every 3 weeks) for up to 9 weeks, or pembrolizumab (every 3 weeks) in combination with CMP-001 for up to 9 weeks. If your treatment includes CMP-001, it will be injected under the skin at the first week of treatment, then directly into the tumor tissue once a week for 6 additional weeks. Following this pre-operative therapy, you will undergo scans to assess the tumor’s response and will then undergo surgery. Surgery is usually done within 2-4 weeks after the scans are completed.
Following recovery from surgery, you will get pembrolizumab alone every 6 weeks for up to 8 treatments.
After you finish your study treatment, your doctor will continue to follow your condition for up to 10 years after you join the study.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04708418
Contact Name: Patient Navigator (uvacancertrials@hscmail.mcc.virginia.edu)
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