Actively Recruiting
Study Evaluating Oral Impact4 Support with Anti PD1 or Anti PD1-Based Treatments 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Oral Impact4 on reducing immune-related side effects in patients with inoperable locally advanced or metastatic melanoma. This single-center, prospective study involves 20 patients who will receive Oral Impact4 to support standard anti-PD1 therapies, such as nivolumab alone or combined with ipilimumab or relatlimab. The study compares results to historical data from similar patients who did not receive Oral Impact4. Participants will take Oral Impact4 starting one week before their anti-PD1 treatment. The dosage is two bricks per day for 21 days, followed by one brick per day for 14 days, totaling 35 days. Anti-PD1 treatment according to clinical practice may continue for up to two years. The study focuses on how this nutritional support affects the frequency and severity of severe immune-related adverse events. During the study, patients will be monitored for immune-related side effects for up to 12 months after treatment ends. Researchers will also evaluate prognostic biomarkers from one week before treatment through the end of treatment. Patients will undergo regular assessments including imaging to measure disease status and laboratory tests to ensure safety. Participation lasts throughout treatment and follow-up periods.
CONDITIONS
Brief 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 stage III unresectable or stage IV cutaneous melanoma
- Planned anti-PD1 therapy (nivolumab alone or combined with ipilimumab or relatlimab) as per clinical practice
- Measurable disease by CT or MRI according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Laboratory values within specified limits before treatment, including adequate blood counts and organ function
- Completed any prior palliative radiotherapy at least 2 weeks before study drug
- Use of adequate contraception if of reproductive potential
- Signed written informed consent
You will not qualify if you...
- Active brain metastases
- Previous malignancies unless in complete remission for at least 2 years
- Prior systemic anticancer therapy for unresectable or metastatic melanoma
- Serious or uncontrolled medical disorders or active infections increasing risk
- Active, known, or suspected autoimmune disease
- Use of systemic corticosteroids or immunosuppressants within 14 days before treatment
- Participation in other interventional drug or device studies within 30 days before treatment
- Active hepatitis B, hepatitis C, or HIV infection
- History of severe hypersensitivity to monoclonal antibodies
- Pregnancy or breastfeeding
- Refusal to use effective contraception if of reproductive potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 35 days
Participants receive Oral Impact® starting one week before anti-PD1 therapy and continue for a total of 35 days while undergoing anti-PD1 or anti-PD1 based regimen treatment.
Approximately weekly visits during treatment
Duration - Up to 12 months
Participants are followed for up to 12 months after end of treatment to assess safety and effectiveness outcomes.
Periodic follow-up visits as per clinical practice
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
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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