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Biomarker hunt: could IFN-Gamma guide melanoma treatment?

NCT ID NCT07436390

Knowledge-focused Sponsor: Institute of Oncology Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This completed study looked at 132 people with advanced melanoma to see if levels of a protein called interferon-gamma (IFN-γ) in their tumors or blood could predict how well they would respond to first-line immunotherapy drugs like pembrolizumab, nivolumab, or a combination. The goal is to find a reliable biomarker to personalize treatment and avoid giving ineffective therapies. The study also explored whether gut bacteria play a role in treatment outcomes.

What this could mean

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

Active substance
Pembrolizumab, Nivolumab, Ipilimumab/Nivolumab
What this could lead to
If successful, this could help doctors choose the right immunotherapy for each patient, improving response rates and reducing unnecessary side effects.
What could go wrong
This is an observational study, not a treatment trial. The biomarker may not reliably predict response, and results may not change clinical practice immediately.

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

132 people

The number who actually took part.

Started

Mar 2024

Finished

Mar 2024

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: * Age over 18 years * Cytologically or histologically verified malignant melanoma * Stage IIID unresectable/IV according to AJCC classification (8th edition, 2018) * Performance status WHO 0-2 (ECOG criteria) * First-line systemic immunotherapy treatment (nivolumab, ipilimumab/nivolumab combination, pembrolizumab) * CT triple scan/PET CT performed within 4 weeks prior to the first administration * Signed informed consent for participation in the clinical study Exclusion Criteria: * Previous systemic therapy for melanoma * Performance status WHO 3-4 (ECOG criteria) * Contraindications for immunotherapy (known immune deficiency, active immunosuppressive treatment, or active autoimmune disease requiring treatment) * Other malignant diseases (except cured basal cell carcinoma, squamous cell carcinoma, and other cured solid tumors without recurrence more than three years after treatment)

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma skin cancer skin neoplasm

As listed by the trial registrant

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

Malignant melanoma Metastatic melanoma Skin cancer

Contacts and locations

Locations

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

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