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Can a drink mix tame Immunotherapy's worst side effects in melanoma?

NCT ID NCT06880198

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a dietary supplement called Oral Impact® can lower the risk of severe side effects from immunotherapy drugs used to treat advanced melanoma. Twenty patients with inoperable locally advanced or metastatic melanoma will take the supplement for 35 days, starting a week before their first immunotherapy dose. Researchers will compare their side effect rates to historical data from similar patients who did not take the supplement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral Impact® (a dietary supplement)
What this could lead to
If it works, this could point toward a way to reduce severe side effects from immunotherapy, making treatment more tolerable for melanoma patients.
What could go wrong
This is a very small, early study with only 20 people, and it compares results to historical data rather than a control group. The supplement may not reduce side effects as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years; 2. Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma; 3. 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; 4. 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; ; 5. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 7. Screening laboratory values must meet the following criteria before starting the treatment: 1. WBCs ≥2000/μL 2. Neutrophils ≥1500/μL 3. Platelets ≥100 x 10³/μL 4. Hemoglobin ≥9.0 g/dL 5. Serum creatinine of ≤1.5 times the upper normal limits or creatinine clearance \>40 mL/minute 6. AST ≤ 3 times the upper normal limits 7. ALT ≤ 3 times the upper normal limits 8. Total bilirubin ≤1.5 times the upper normal limits (except patients with Gilbert Syndrome who must have total bilirubin \<3.0 mg/dL) 8. Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration; 9. Patients of reproductive potential, must use adequate contraception methods; 10. Signed written consent form; Exclusion Criteria: 1. Active brain metastases; 2. Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry; 3. Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma; 4. 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; 5. Presence of active, known, or suspected autoimmune disease; 6. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment; 7. Participation in any interventional drug or medical device study within 30 days prior to treatment start; 8. 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; 9. History of severe hypersensitivity reactions to other monoclonal antibodies; 10. Pregnant and breast-feeding women; 11. Patients of reproductive who refuse to use effective methods of contraception.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istituto Nazionale Tumori IRCCS - Fondazione "G. Pascale"

    RECRUITING

    Naples, 80131, Italy

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