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Site for EA6192: A Phase II Study of Biomarker Driven Early Discontinuation of anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) (PSCI# 20-097)

The purpose of this study is to compare the safety and effects of stopping the standard treatment with nivolumab or pembrolizumab early with the safety and effects of not stopping the standard treatment early on people’s risk of having advanced melanoma cancer spread more. In this study, you will continue on your standard of care treatment for one more year or you will discontinue your standard of care treatment. Whether you continue or stop treatment is dependent on the results of a PET/CT scan and, if needed, a biopsy. PET/CT scan can be useful for monitoring your type of cancer. There will be about 150 people taking part in this study.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patient must be ≥ 18 years of age.
Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by AJCC 8th edition
Patient must have an ECOG performance status of 0-2
Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy
For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable
Exclusion Criteria:
Patient must not have brain metastases
Women must not be pregnant or breast-feeding
Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens
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Hershey, PA