Evaluating biomarkers for melanoma immunotherapy response
Effectiveness of Immunotherapy in the First-line Treatment of Disseminated Melanoma and Recognition of Prognostic and Predictive Biomarkers From the Primary Tumor, Stool and Body Fluids: PROTOCOL TRIAL
This study is testing whether certain gut bacteria and blood markers can help predict how well immunotherapy works for people with advanced melanoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, immunotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05878977 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unresectable stage IIID or IV malignant melanoma who are starting first-line immunotherapy.
Not a fit: Patients with previously treated melanoma or those with contraindications for immunotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for immunotherapy, enhancing treatment outcomes for those with metastatic melanoma.
How similar studies have performed: Other studies have shown promise in using biomarkers to predict responses to immunotherapy, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Tanja Mesti
- Email: tmesti@onko-i.si
- Phone: 0038615879287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.