This is a monocentric, prospective study evaluating the effectiveness in reducing immune-related adverse events, and translational study conducted on 20 patients with inoperable locally advanced or metastatic melanoma.
The patients will be treated with Oral Impact® administered at the dose of two bricks/day for 21 days + one brick/day for 14 days, starting exactly one week before Anti PD-1 treatment (nivolumab) or anti PD1 based regimen therapy (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) as per clinical practice.
The comparison will be done with historical literature data on patients matched by age, sex, disease stage, and therapy dosage, not treated with Impact.
Age ≥ 18 years;
Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma;
PD-L1 evaluation and as per standard clinical practice, patients with PD-L1 < 1% will be treated with anti PD1 based regimen and patients with PD-L1>1% will be treated with anti-PD1 in monotherapy;
Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and decision by the treating oncologist; ;
Active brain metastases;
Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;
Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;
Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy;
Single group
Oral Impact®
Dietary supplementOne Arm: 2 Impact brick/d for 21 days + 1 brick/d for 14 days, starting exactly one week before Anti PD-1 treatment in patients with inoperable locally advanced or metastatic melanoma Treatment duration: 35 days
the role of immunonutrition with Oral Impact® in reducing G3 - G4 irAEs frequency and severity grade of anti-PD1 therapy (Nivolumab) or anti-PD1 based regimen in patients with inoperable locally advanced or metastatic melanoma.
Prognostic bio-markers evaluation
Evaluation of peripheral blood biomarkers, metagenomic sequencing of gut microbiota, gene profile analysis, and, if archived tissues are available, tumor tissue biomarkers.
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