Clinical Trials | A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have advanced melanoma. The purpose of this study is to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy. In order to participate in this study, eligibility requirements must be met. Some requirements include receiving anti-PD-1 therapy and be less than 56 weeks from starting the therapy, not receiving other type of anti-tumor therapies, and completing an FDG-PET/CT scan one year after starting anti-PD-1 therapy. Once it is confirmed that you are eligible for the study, you will be placed in one of two groups based on the FDG-PET/CT scan and the tumor biopsy. One group will stop their anti-PD-1 treatment a year of therapy and the other group will continue to use their anti-PD-1 treatment for another year. Your visits will be every 12 weeks. You will have more exams, tests, procedures to closely monitor your safety and health. 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/NCT04462406 [email protected] The (department, division name) seeks (insert as applies: adults/men/women/adolescents/children) ages (insert) with (insert condition) for a research study. The purpose of the study is (insert purpose of study - eg.to test the effectiveness of an investigational medicine; or to find out how stress effects blood pressure.) (Optional)You may be eligible for this study if: (insert brief eligibility criteria 3 or 4 top criteria and in lay language. Do not copy eligibility criteria from the protocol) Study involves (insert procedures-examples: taking an experimental medicine/placebo, blood draws, x rays, overnight stays,) (Insert x number of visits every x (weeks, months,) each visit lasting x amount of time or give range). Insert one of the following: Study-related (insert exams, tests and experimental medication) provided at no cost. or Participant’s insurance company will be billed for medication, tests and procedures