Can a drink mix tame Immunotherapy's worst side effects in melanoma?
NCT ID NCT06880198
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
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Istituto Nazionale Tumori IRCCS - Fondazione "G. Pascale"
RECRUITINGNaples, 80131, Italy
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