Evaluating biomarkers for melanoma immunotherapy response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between gastrointestinal microbiome composition, exosomal mRNA expression of PD-L1 and IFNγ, and the effectiveness of immune checkpoint inhibitors in treating metastatic melanoma. Patients receiving first-line immunotherapy will provide stool and blood samples at various time points to assess these biomarkers. The goal is to identify potential predictors of treatment response, which could enhance personalized treatment strategies for melanoma patients.

Why it matters

Who can join: the full rules

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 according to WHO 0 - 2 (ECOG criteria)
* 1st line of systemic treatment with immunotherapy (nivolumab, ipi/nivo, pembrolizumab)
* Triple CT/PET CT done within 4 weeks before the first application
* Signed consent to participate in clinical research

Exclusion Criteria:

* Previously treated melanoma with systemic therapy
* Capacity status according to WHO 3 - 4 (ECOG criteria)
* Contraindications for immunotherapy treatment (known deficiency of the immune system or active immunosuppressive treatment or active autoimmune disease requiring treatment)
* Other malignant diseases (except cured basal cell carcinoma and squamous cell carcinoma)

Where it's running

• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Tanja Mesti
• Email: tmesti@onko-i.si
• Phone: 0038615879287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.