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

NCT06880198 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Melanoma Metastatic
  • Locally Advanced Melanoma

Interventions

DIETARY_SUPPLEMENT

Oral 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

Sponsors & Collaborators

  • Fondazione Melanoma Onlus

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880198 on ClinicalTrials.gov