Metastatic MelanomaPREMIONCT07794501
Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma
An observational study of Metastatic Melanoma, run by European Institute of Oncology.
Trial summary
Cutaneous melanoma is an aggressive malignancy with a rising global incidence; its prognosis has been radically transformed by immune checkpoint inhibitors (ICIs), a class of immunotherapeutic agents targeting immune regulatory pathways such as programmed cell death protein 1 (PD-1), cytotoxic T-lymphocyte-associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2026to 30 Nov 2027
- Phase
- Observational
- 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
Study population: The study will include patients who received an immune checkpoint inhibitors agent for their metastatic melanoma from 01/01/2022 until 30/11/2027 at IEO, Milan.
Who may be able to join
- Patients with a diagnosis of metastatic or locally advanced unresectable melanoma
- Patients treated with first-line immunotherapy as monotherapy (e.g., pembrolizumab or nivolumab) or in combination (e.g., ipilimumab - nivolumab or nivolumab - relatlimab)
- Patients treated at IEO (Milan) from 01/01/2022 to 30/11/2027
- Age ≥18 years
Who cannot join
- Patients who received targeted therapy as first-line treatment for metastatic melanoma
- Patients with a diagnosis of resectable stage III melanoma or operated stage IV with no evidence of disease (NED)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Identifying Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma: the PREMIO Study
Cutaneous melanoma is an aggressive malignancy with a rising global incidence; its prognosis has been radically transformed by immune checkpoint inhibitors (ICIs), a class of immunotherapeutic agents targeting immune regulatory pathways such as programmed cell death protein 1 (PD-1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and lymphocyte activation gene 3 (LAG-3). Currently approved first-line treatment strategies-including anti-PD-1 monotherapy and the combinations of nivolumab plus ipilimumab and nivolumab plus relatlimab-have demonstrated significant survival benefits, although combination regimens are associated with a considerably more burdensome toxicity profile compared with monotherapy. Despite these major therapeutic advances, the optimal treatment choice for each individual patient remains uncertain, primarily due to the lack of validated predictive biomarkers in the metastatic setting. This unmet clinical need represents the central rationale of the present study, which aims to bridge this gap through the systematic collection and integrated analysis of clinical, pathological, and molecular data from approximately 200 patients treated with first-line immunotherapy at the European Institute of Oncology.
- Conditions
- Metastatic Melanoma
- Keywords
- Immunotherapy, Mestastatic melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival Rate
The progression-free survival (PFS) rate will be evaluated to identify clinical and/or biological predictive markers of efficacy of first-line immune checkpoint inhibitor (ICI) therapy in patients with metastatic melanoma treated at the European Institute of Oncology (IEO), receiving either ICI monotherapy (pembrolizumab or nivolumab) or ICI combination therapy (nivolumab plus ipilimumab or nivolumab plus relatlimab).
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Real-world Overall Survival
Real-world Overall Survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start27 Aug 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (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.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Blank, MD, Study director, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794501
- Sponsor's protocol ID
- UID 5480
- Other IDs
- L2-695
- Acronym
- PREMIO
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma: the PREMIO Study
- ClinicalTrials.gov ID
- NCT07794501
- Acronym / sponsor ID
- PREMIO / UID 5480
- Conditions
- Metastatic Melanoma
- Keywords
- Immunotherapy, Mestastatic melanoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 27 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 31 Aug 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.
Cutaneous melanoma is an aggressive malignancy with a rising global incidence; its prognosis has been radically transformed by immune checkpoint inhibitors (ICIs), a class of immunotherapeutic agents targeting immune regulatory pathways such as programmed cell death protein 1 (PD-1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and lymphocyte activation gene 3 (LAG-3). Currently approved first-line treatment strategies-including anti-PD-1 monotherapy and the combinations of nivolumab plus ipilimumab and nivolumab plus relatlimab-have demonstrated significant survival benefits, although combination regimens are associated with a considerably more burdensome toxicity profile compared with monotherapy. Despite these major therapeutic advances, the optimal treatment choice for each individual patient remains uncertain, primarily due to the lack of validated predictive biomarkers in the metastatic setting. This unmet clinical need represents the central rationale of the present study, which aims to bridge this gap through the systematic collection and integrated analysis of clinical, pathological, and molecular data from approximately 200 patients treated with first-line immunotherapy at the European Institute of Oncology.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients who received an immune checkpoint inhibitors agent for their metastatic melanoma from 01/01/2022 until 30/11/2027 at IEO, Milan.
Key inclusion criteria (4 listed)
- Patients with a diagnosis of metastatic or locally advanced unresectable melanoma
- Patients treated with first-line immunotherapy as monotherapy (e.g., pembrolizumab or nivolumab) or in combination (e.g., ipilimumab - nivolumab or nivolumab - relatlimab)
- Patients treated at IEO (Milan) from 01/01/2022 to 30/11/2027
- Age ≥18 years
Key exclusion criteria (2 listed)
- Patients who received targeted therapy as first-line treatment for metastatic melanoma
- Patients with a diagnosis of resectable stage III melanoma or operated stage IV with no evidence of disease (NED)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival Rate
Time frame: through study completion, an average of 1 year
The progression-free survival (PFS) rate will be evaluated to identify clinical and/or biological predictive markers of efficacy of first-line immune checkpoint inhibitor (ICI) therapy in patients with metastatic melanoma treated at the European Institute of Oncology (IEO), receiving either ICI monotherapy (pembrolizumab or nivolumab) or ICI combination therapy (nivolumab plus ipilimumab or nivolumab plus relatlimab).
1 secondary outcome
Real-world Overall Survival
Time frame: through study completion, an average of 1 year
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 31 Aug 2026.
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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.
Christian Blank, MD study director
Istituto Europeo di Oncologia
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by European Institute of Oncology.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Gabriele Antonarelli, MD (+39 02 57489265, gabriele.antonarelli@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival Rate (time frame: through study completion, an average of 1 year). 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 31 Aug 2026.