Clinical Trials | A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have melanoma that cannot be removed by surgery. The purpose of this study is to determine if a new investigational drug, LNS8801, is safe and helpful in patients with melanoma that has progressed after the use of standard treatments. In this study, the effects of LNS8801 will be studied when given with and without a drug known as pembrolizumab, an FDA approved monoclonal antibody that is used to treat various types of cancer. This is an open-label study. This means that you, the study doctor, study staff, and the Sponsor will know the study medicines you are given. This is a randomized study. This means that you will be assigned to one of 3 groups. • Two thirds of subjects will receive LNS8801 • One third will receive an FDA approved immunotherapy or chemotherapy of their and their physician’s choice. • Half of the subjects receiving LNS8801 will receive LNS8801 alone and half will receive LNS8801 in combination with pembrolizumab. The length of time you are in the study and the number of visits to the study center will depend on how many cycles you complete. Your participation in this study will be for approximately two 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/NCT06624644 [email protected]