Actively Recruiting
Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma
Led by Fondazione Melanoma Onlus · Updated on 2025-09-17
20
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed unresectable stage III or stage IV cutaneous melanoma
- PD-L1 testing to guide treatment: PD-L1 < 1% for anti-PD1 based regimen or PD-L1 > 1% for anti-PD1 monotherapy
- Planned treatment with anti-PD1 (Nivolumab) alone or combined with Ipilimumab or Relatlimab
- Measurable disease by CT or MRI according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Screening labs within required limits for white blood cells, neutrophils, platelets, hemoglobin, creatinine, AST, ALT, and bilirubin
- Completed any prior palliative radiotherapy at least 2 weeks before starting study treatment
- Use of adequate contraception for patients of reproductive potential
- Signed informed consent form
You will not qualify if you...
- Presence of active brain metastases
- Previous cancers unless in complete remission for at least 2 years
- Prior systemic anticancer therapy for unresectable or metastatic melanoma
- Serious or uncontrolled medical conditions or active infections increasing study risk or impairing treatment
- Active, known, or suspected autoimmune disease
- Need for systemic corticosteroids or immunosuppressive medications within 14 days before treatment
- Participation in another interventional drug or device study within 30 days before treatment
- Active hepatitis B, hepatitis C, or HIV infection
- History of severe allergic reactions to monoclonal antibodies
- Pregnant or breastfeeding women
- Patients of reproductive potential refusing effective contraception methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Nazionale Tumori IRCCS - Fondazione "G. Pascale"
Naples, Italy, 80131
Actively Recruiting
Research Team
P
Paolo A. Ascierto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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