The objective of this prospective multicenter study is to evaluate whether the analysis of immunological biomarkers present in circulating extracellular vesicles is associated with the response to anti-PD-1/PD-L1 treatments in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or unresectable melanoma.
Patients will receive standard-of-care treatment and will be followed according to routine clinical practice. The study involves the collection of four study-specific blood samples at different time points during follow-up, as well as the collection of standard immunohistochemistry results, thoraco-abdomino-pelvic CT scans, and tumor DNA genotyping analyses performed as part of routine care.
The study aims to determine:
* whether baseline biomarkers in extracellular vesicles are associated with response to anti-PD-1/PD-L1 treatment,
* how these biomarkers change over the course of treatment, and
* to provide exploratory data for the development of predictive immunological response signatures.