RecruitingNot ApplicableNCT06880198

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

An Interventional, Not Pharmacological Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma


Sponsor

Fondazione Melanoma Onlus

Enrollment

20 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a nutritional supplement called Impact — which contains specific nutrients thought to support the immune system — alongside standard immunotherapy (anti-PD-1 drugs) for people with advanced melanoma (skin cancer that has spread or cannot be removed). The goal is to see whether the supplement improves treatment outcomes. **You may be eligible if:** - You are 18 or older - You have been confirmed by biopsy to have stage III (unresectable) or stage IV melanoma - You are about to start treatment with an anti-PD-1 immunotherapy drug (alone or in combination) - Your PD-L1 status has been assessed as part of standard care **You may NOT be eligible if:** - Your melanoma is at an earlier stage that can be surgically removed - You have already received immunotherapy for your melanoma - You have serious autoimmune disease or other conditions that make immunotherapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DIETARY_SUPPLEMENTOral Impact®

One 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


Locations(1)

Istituto Nazionale Tumori IRCCS - Fondazione "G. Pascale"

Napoli, Italy

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NCT06880198


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