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Clinical Trials | A Phase 3 Research study for patients with previously untreated Advanced Melanoma

A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants with Previously Untreated Advanced Melanoma

The UVA Cancer Center has a clinical trial for adults over the age of 18 and who have Advanced Melanoma without prior medical treatment. You will also need to test positive for HLA-A *02:01. The purpose of this Phase 3 study is to test the efficacy of various doses of Brenetafusp (IMC-F106C) with Nivolumab versus Nivolumab regimens. There are three different treatment groups for this study – lower dose of Brenetafusp + Nivolumub, higher dose of Brenetafusp + Nivolumab, or Nivolumab + Relatimab. The overall trial does not have a set duration, study treatment will continue for as long as your study doctor thinks the medicine is helping you or another reason for discontinuation has been presented. If you discontinue study drug for reasons other than confirmed disease progression you will be followed for ongoing tumor assessments until your disease gets worse or you start a new anticancer treatment. You will be reimbursed up to $200 per night for lodging for completed appointments for the duration of this study. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. The Safety Follow-Up Period will continue until 100 days have elapsed after the last dose of study intervention, subsequent anticancer therapy is started, or the participant withdraws consent for further study procedures (whichever occurs first). Once the safety follow up is completed, the team will continue to contact you every 3 months via telephone to assess your overall health and ask about any new therapies. Study involves taking an experimental medicine or standard of care treatment, blood draws, tumor imaging, overnight stays. Depending on your assigned study arm, there will be weekly drug administration for the first 13 weeks, then every 2 weeks through week 53, and then every 4 weeks or every 4 weeks only. [email protected]