Metastatic MelanomaMAKNCT07422779
Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
A study testing Pembrolizumab, Nivolumab and Ipilimumab in people with Metastatic Melanoma and Skin Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, Skin Cancer
- What is being tested?
- Pembrolizumab, Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2022to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Cytologically or histologically confirmed metastatic malignant melanoma
- Stage IIID unresectable or stage IV (AJCC 8th edition)
- ECOG performance status 0-2
- First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab/nivolumab)
- CT/PET-CT performed within 4 weeks prior to treatment start
- Signed informed consent
Who cannot join
- Previous systemic therapy for melanoma
- ECOG performance status 3-4
- Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)
- Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence >3 years)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Klavdija Korošec, +386 31630065, kkorosec@onko-i.si
Neža Gros, ngros@onko-i.si
About this study
Official title: Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood
The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.
Read the detailed description
This study evaluates the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and investigates the predictive value of PD-L1 expression in tumor tissue and blood. The aim is to assess the association between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to treatment with immune checkpoint inhibitors. In addition, the study evaluates the association between the occurrence of immune-related adverse events and survival.
- Conditions
- Metastatic Melanoma, Skin Cancer
- Being tested
- Pembrolizumab, Nivolumab, Ipilimumab
- Keywords
- Immunotherapy, Immune Checkpoint Inhibitors
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.
NivolumabDrug
Nivolumab is a PD-1 immune checkpoint inhibitor administered as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice, either as monotherapy or in combination with ipilimumab.
IpilimumabDrug
Ipilimumab is a CTLA-4 immune checkpoint inhibitor administered in combination with nivolumab as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 inhibitor therapy | Other | Participants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice. Receives: Drug: Pembrolizumab; Drug: Nivolumab |
| Combination PD-1 and CTLA-4 inhibitor therapy | Other | Participants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice. Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to irRECIST
Objective response will be assessed using CT or PET/CT imaging and evaluated according to irRECIST criteria. The outcome will be reported as the proportion (%) of participants achieving complete response (CR) or partial response (PR).
Measured: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)
Secondary outcomes (1)
PD-L1 Expression in Tumor Tissue (Immunohistochemistry, H-score or % Positive Cells)
PD-L1 expression in tumor tissue will be assessed using immunohistochemistry (IHC). The outcome will be reported as PD-L1 expression level (H-score and/or percentage of PD-L1 positive tumor cells) and correlated with objective response according to irRECIST.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized comparative study evaluating response to immune checkpoint inhibitors in first-line treatment of metastatic melanoma and association with PD-L1 expression in tumor tissue and blood.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422779
- Sponsor's protocol ID
- OI-693-MEL-PDL1-2022
- Acronym
- MAK
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood
- ClinicalTrials.gov ID
- NCT07422779
- Acronym / sponsor ID
- MAK / OI-693-MEL-PDL1-2022
- Conditions
- Metastatic Melanoma, Skin Cancer
- Keywords
- Immunotherapy, Immune Checkpoint Inhibitors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.
Detailed description
This study evaluates the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and investigates the predictive value of PD-L1 expression in tumor tissue and blood. The aim is to assess the association between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to treatment with immune checkpoint inhibitors. In addition, the study evaluates the association between the occurrence of immune-related adverse events and survival.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized comparative study evaluating response to immune checkpoint inhibitors in first-line treatment of metastatic melanoma and association with PD-L1 expression in tumor tissue and blood.
| Arm | Type | Receives |
|---|---|---|
| PD-1 inhibitor therapy | Other | Drug: Pembrolizumab, Drug: NivolumabParticipants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice. |
| Combination PD-1 and CTLA-4 inhibitor therapy | Other | Drug: Nivolumab, Drug: IpilimumabParticipants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Cytologically or histologically confirmed metastatic malignant melanoma
- Stage IIID unresectable or stage IV (AJCC 8th edition)
- ECOG performance status 0-2
- First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab/nivolumab)
Key exclusion criteria (4 listed)
- Previous systemic therapy for melanoma
- ECOG performance status 3-4
- Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)
- Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence >3 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice. | Drug | PD-1 inhibitor therapy |
| NivolumabNivolumab is a PD-1 immune checkpoint inhibitor administered as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice, either as monotherapy or in combination with ipilimumab. | Drug | Combination PD-1 and CTLA-4 inhibitor therapy, PD-1 inhibitor therapy |
| IpilimumabIpilimumab is a CTLA-4 immune checkpoint inhibitor administered in combination with nivolumab as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice. | Drug | Combination PD-1 and CTLA-4 inhibitor therapy |
Primary outcome
Objective Response Rate (ORR) According to irRECIST
Time frame: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)
Objective response will be assessed using CT or PET/CT imaging and evaluated according to irRECIST criteria. The outcome will be reported as the proportion (%) of participants achieving complete response (CR) or partial response (PR).
1 secondary outcome
PD-L1 Expression in Tumor Tissue (Immunohistochemistry, H-score or % Positive Cells)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pembrolizumab, Nivolumab and Ipilimumab in people with Metastatic Melanoma and Skin Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanja Mesti, MD (+386 1 587 9000, tmesti@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) According to irRECIST (time frame: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.