H. Lee Moffitt Cancer Center and Research Institute
The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.
Inclusion Criteria: * Age ≥18 years * Histologically confirmed melanoma (excluding uveal melanoma) * Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma * Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma * ECOG Performance Status ≤2 * Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN. * Baseline imaging obtained within 28 days prior to treatment initiation * Negative pregnancy test for women of childbearing potential * Ability to understand and sign informed consent Excl…
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules.
Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation.
Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation.
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