Clinical Trials | An Expanded Access Program – Real-world Data Collection for VO in Combination with Nivolumab in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 Containing Treatment Regimen

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have advanced melanoma that has progressed on an Anti-PD-1 containing treatment regimen. The purpose of the study is to provide access to Vusolimogene Oderparepvec (VO) for combination with standard of care nivolumab to patients with advanced melanoma that have previously been treated with an aPD-1 blocking antibody. In this study you will receive the following treatment: VO is an investigational drug, which means the health authorities have not approved VO for the treatment of melanoma. Nivolumab, which is approved by the FDA is available by prescription to treat several different cancers, including melanoma. You will receive both drugs via IV into your arm. Your first dose of study drug will be VO alone. This will be the first of up to 8 doses of VO. If your tumors are on the skin or under it but can be touched or felt, VO can be injected directly. An ultrasound (imaging of your body using sounds waves) or a CT scan may also be used to help the study doctor to inject VO directly into the deep tumors if you have them. Starting with the second dose at week 3, VO will be given every 2 weeks together with nivolumab. Treatment with VO will last approximately 16 weeks (8 doses in total). If your study doctor thinks it may be beneficial to you, you may receive additional courses each of up to eight (8) injections of VO with or without nivolumab over the course of 16 weeks. You could receive study treatment up to 44 weeks. You are expected to be in this study for up to 16 months. 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/NCT06590480 [email protected]