Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma

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 pat

Trial Details

NCT ID
NCT06880198
Phase
NA
Sponsor
Fondazione Melanoma Onlus
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Oral Impact®
Locations (sample)
  • Naples, Italy|40.85216,14.26811

Key Eligibility Criteria

  • 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-…
  • Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice a…

For full eligibility, visit ClinicalTrials.gov.

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