The University of Virginia is conducting a clinical research study for adults ages 18 and over who have untreated, unresectable or metastatic melanoma. The purpose of this study is to see how lifileucel (study treatment) plus a treatment called pembrolizumab is as good, the same, better or worse than treating your type of cancer with pembrolizumab. Lifileucel is a type of medicine known as immunotherapy, that uses your body’s immune system to fight cancer. Lifileucel is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells known as lymphocytes or “T cells” obtained from a piece your tumor. T cells are a part of your immune system that help your body fight against infections and diseases including cancer.
If you participate in this study you will be randomized 1:1 to receive either lifileucel and pembrolizumab (Arm A) or pembrolizumab alone (Arm B). Randomization means that treatment is assigned by chance. 1:1 means that you have an equal chance of being in either arm. If you are randomized to Arm B, you could have the option of crossing over to Arm A to receive lifileucel treatment.
Your participation in this study may vary depending on how you react to the study treatment. You could be in this study for up to 7 years.
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/study/NCT05727904
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