Melanoma Trial, Recruiting NCT06880198 Sponsor: Fondazione Melanoma Onlus Condition: Melanoma
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Melanoma Trial, Recruiting

NCT06880198
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older.
  • People who have been diagnosed with skin melanoma (cutaneous melanoma) that is either at an advanced stage that cannot be surgically removed (stage III unresectable) or has spread to other parts of the body (stage IV), confirmed by tissue testing.
  • People whose tumour has been tested for a protein called PD-L1, with treatment planned based on those results, as decided by their treating cancer doctor.
  • People for whom a specific type of immunotherapy — Nivolumab alone, Nivolumab combined with Ipilimumab, or Nivolumab combined with Relatlimab — has been planned as standard treatment by their treating cancer doctor.
  • People whose cancer can be measured using CT or MRI scans according to a standard measurement system called RECIST 1.1.
  • People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard medical scale called the ECOG performance scale (meaning fully active or able to do light activity).
  • People whose blood test results before starting treatment meet specific levels for white blood cells, neutrophils (infection-fighting cells), platelets, haemoglobin, kidney function, and liver function (confirm with trial site for exact values).
  • People who have finished palliative radiotherapy at least 2 weeks before starting the trial treatment.
  • People of reproductive potential who are willing to use adequate contraception throughout the trial.
  • People who are willing and able to sign a written consent form.

Who may not be able to join:

  • People who currently have active cancer that has spread to the brain.
  • People who have had a different cancer in the past, unless they have been in complete remission for at least 2 years before joining the trial.
  • People who have previously received systemic (whole-body) anti-cancer treatment for unresectable or metastatic melanoma.
  • People with a serious, uncontrolled medical condition or active infection that, in the trial doctor's opinion, could increase the risks of participation or interfere with treatment.
  • People who have an active autoimmune disease (where the immune system attacks the body's own tissues).
  • People who have needed to take corticosteroids (such as prednisone) or other immune-suppressing medications regularly within the 14 days before starting treatment.
  • People who have taken part in another clinical drug or medical device trial within 30 days before starting this trial.
  • People who have active Hepatitis B, active Hepatitis C, or active HIV infection.
  • People who have had a severe allergic reaction to a type of medication called monoclonal antibodies in the past.
  • People who are pregnant or breastfeeding.
  • People of reproductive potential who are not willing to use effective contraception.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +39 08117775088

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Fondazione Melanoma Onlus
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
1 July 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov