Melanoma MetastaticMELA-IMPACTNCT06880198
Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma
A study testing Oral Impact® in people with Melanoma Metastatic and Locally Advanced Melanoma, run by Fondazione Melanoma Onlus at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic, Locally Advanced Melanoma
- What is being tested?
- Oral Impact®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-L1>1% will be treated with anti-PD1 in monotherapy;
- Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and decision by the treating oncologist; ;
- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
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- Screening laboratory values must meet the following criteria before starting the treatment:
- WBCs ≥2000/μL
- Neutrophils ≥1500/μL
- Platelets ≥100 x 10³/μL
- Hemoglobin ≥9.0 g/dL
- Serum creatinine of ≤1.5 times the upper normal limits or creatinine clearance >40 mL/minute
- AST ≤ 3 times the upper normal limits
- ALT ≤ 3 times the upper normal limits
- Total bilirubin ≤1.5 times the upper normal limits (except patients with Gilbert Syndrome who must have total bilirubin <3.0 mg/dL)
- Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration;
- Patients of reproductive potential, must use adequate contraception methods;
- Signed written consent form;
Who cannot join
- Active brain metastases;
- Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;
- Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy;
- Presence of active, known, or suspected autoimmune disease;
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment;
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- Participation in any interventional drug or medical device study within 30 days prior to treatment start;
- Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or active C hepatitis or active HIV;
- History of severe hypersensitivity reactions to other monoclonal antibodies;
- Pregnant and breast-feeding women;
- Patients of reproductive who refuse to use effective methods of contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paolo A. Ascierto contact
p.ascierto@istitutotumori.na.it; melaimpact@cr-technology.com
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori IRCCS - Fondazione "G. Pascale"
Naples, 80131
Paolo A. Ascierto, +39 081 17775088, p.ascierto@istitutotumori.na.it
About this study
Official title: 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
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
- Being tested
- Oral Impact®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Impact®Dietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Oral Impact®: single arm | Experimental | 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, administered up to two years. Receives: Dietary Supplement: Oral Impact® |
What is being measured
The primary outcome is the main question the study is designed to answer.
the role of immunonutrition with Oral Impact® in reducing G3 - G4 irAEs frequency and severity grade of anti-PD1 therapy (Nivolumab) or anti-PD1 based regimen in patients with inoperable locally advanced or metastatic melanoma.
Measured: up to 12 months from EoT
Secondary outcomes (1)
Prognostic bio-markers evaluation
Evaluation of peripheral blood biomarkers, metagenomic sequencing of gut microbiota, gene profile analysis, and, if archived tissues are available, tumor tissue biomarkers.
Measured: from day -7 up to EoT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Aug 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Melanoma Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880198
- Sponsor's protocol ID
- MELA-IMPACT
- Acronym
- MELA-IMPACT
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06880198
- Acronym / sponsor ID
- MELA-IMPACT / MELA-IMPACT
- Conditions
- Melanoma Metastatic, Locally Advanced Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Melanoma OnlusUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Impact®: single arm | Experimental | Dietary Supplement: Oral Impact®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, administered up to two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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-L1>1% will be treated with anti-PD1 in monotherapy;
- Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and decision by the treating oncologist; ;
- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
Key exclusion criteria (11 listed)
- Active brain metastases;
- Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry;
- Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma;
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy;
- Presence of active, known, or suspected autoimmune disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Oral Impact®: single arm |
Primary outcome
the role of immunonutrition with Oral Impact® in reducing G3 - G4 irAEs frequency and severity grade of anti-PD1 therapy (Nivolumab) or anti-PD1 based regimen in patients with inoperable locally advanced or metastatic melanoma.
Time frame: up to 12 months from EoT
1 secondary outcome
Prognostic bio-markers evaluation
Time frame: from day -7 up to EoT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo A. Ascierto contact
p.ascierto@istitutotumori.na.it; melaimpact@cr-technology.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Impact® in people with Melanoma Metastatic and Locally Advanced Melanoma, run by Fondazione Melanoma Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo A. Ascierto (+39 08117775088, p.ascierto@istitutotumori.na.it; melaimpact@cr-technology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the role of immunonutrition with Oral Impact® in reducing G3 - G4 irAEs frequency and severity grade of anti-PD1 therapy (Nivolumab) or anti-PD1 based regimen in patients with inoperable locally advanced or metastatic melanoma. (time frame: up to 12 months from EoT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.