Serial ctDNA Monitoring as a Prognostic and Predictive Biomarker in Advanced Melanoma (SAMBA)

Aim/goals:

1. To correlate the presence of detectable ctDNA after surgery with worse recurrence free survival in high risk melanoma patients.
2. To assess kinetics of ctDNA over time and correlate their changes with survival outcomes in high-risk melanoma patients undergoing adjuvant treatment.
3. To evaluate the correlation between baseline ctDNA detectability and clearance throughout adjuvant treatment and clinical outcomes in patients receiving immunotherapy versus targeted agents.

Localized and surgically resected melanoma is a complex disease with a wide range of survival outcomes. No reliable criteria are available to stratify the risk that the disease may reoccur and identify patients who will benefit from anticancer therapies, sparing the others from unnecessary side effects. Circulating tumor DNA (ctDNA) is a promising biomarker that can measure the presence of tumor genetic material in the blood and identify cancer cells through an easily accessible blood draw even before the CT scan detection. SAMBA is a prospective, non-interventional study for the collection of blood samples, focusing on the potential role of ctDNA as predictive/prognostic biomarker in high-risk melanoma patients. Longitudinal blood collections are performed before local treatment (optional), after local treatment (baseline) and every 3-6 months (around the time of restaging) for up to 2 years.  In parallel, archival tissue is requested from the patients included in this study to perform tissue-based genomic profiling with the purpose to deepen our knowledge of the molecular landscape of high-risk melanoma and enable the optimization of the adjuvant treatment. Patients diagnosed with high-risk melanoma (stage IIB, IIIA, IIIB, IIIC, and IIID or resected IV), undergoing adjuvant treatment with immunotherapy or targeted agents or surveillance follow up are eligible to participate in the trial.