Metastatic Malignant MelanomaMEL-CARENCT07256184
Prognostic and Treatment-Response Factors in Metastatic Melanoma: Multi-Center Analysis
An observational study of Metastatic Malignant Melanoma, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This multicenter, retrospective observational study aims to identify clinical, pathological, and molecular factors associated with prognosis and treatment response in patients with metastatic malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Melanoma
- What is being tested?
- Systemic Therapy for Metastatic Melanoma
- How many people
- 232 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients with metastatic malignant melanoma treated with standard systemic therapy, including immune checkpoint inhibitors, BRAF/MEK inhibitors, or chemotherapy. Data were extracted retrospectively from electronic medical records across multiple oncology centers in Türkiye.
Who may be able to join
- Age ≥18 years
- Histologically or cytologically confirmed metastatic malignant melanoma
- Received ≥1 line of systemic therapy
- Complete baseline and follow-up data
- At least one measurable lesion or clinical response assessment
- Managed between November 2022 - December 2024 at participating centers
Who cannot join
- Incomplete clinical or pathological data
- Uncertain or revised diagnosis
- Metastasis developing outside the inclusion window
- Another primary malignancy (except allowed types)
- Lost to follow-up before first response assessment
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06210
Gazi University, Medical Oncology Department
Ankara, Çankaya
About this study
Official title: Evaluation of Clinical, Pathologic, and Molecular Determinants of Prognosis and Treatment Response in Patients With Metastatic Malignant Melanoma: A Multicenter Retrospective Study
This multicenter, retrospective observational study aims to identify clinical, pathological, and molecular factors associated with prognosis and treatment response in patients with metastatic malignant melanoma. Medical records of adult patients diagnosed and treated between November 2022 and December 2024 at participating oncology centers in Türkiye were reviewed.
Data collected include demographic features, disease characteristics, histopathologic findings, treatment modalities (immune checkpoint inhibitors, targeted therapy, or chemotherapy), and dermatologic adverse events. These variables will be analyzed in relation to survival outcomes to provide real-world evidence supporting personalized management strategies in metastatic melanoma.
Read the detailed description
This multicenter retrospective cohort study evaluates clinical, pathological, and molecular factors that may influence prognosis and treatment response in patients with metastatic malignant melanoma treated between November 2022 and December 2024. The study focuses on routinely collected real-world data, including demographic characteristics, disease features, systemic treatment regimens, and dermatologic adverse events.
The primary analytical objectives are to assess associations between baseline variables and treatment outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Objective Response Rate (ORR). Dermatologic and systemic toxicities graded using CTCAE v5.0 will also be explored for their potential impact on treatment continuity and outcomes. The study uses descriptive statistics, survival analyses, and Cox regression models. No experimental interventions are assigned, and all treatments were delivered as part of routine clinical practice.
This description provides an overview of study intent and analytic framework without duplicating detailed eligibility criteria or outcome definitions recorded in other submission fields.
- Conditions
- Metastatic Malignant Melanoma
- Being tested
- Systemic Therapy for Metastatic Melanoma
- Keywords
- melanoma, metastatic melanoma, prognosis, treatment response, immunotherapy, targeted therapy, BRAF mutation, PD-1 inhibitors, CTLA-4 inhibitors, dermatologic toxicity, adverse events
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic Therapy for Metastatic MelanomaDrug
Standard systemic treatments administered for metastatic malignant melanoma, including immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab), targeted therapy (dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib), and chemotherapy (dacarbazine or temozolomide regimens). All treatments were provided as part of routine institutional clinical practice. No investigational or randomized assignment was performed. Treatment information was collected retrospectively from medical records for evaluation of prognostic and treatment-response outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Multicenter Metastatic Melanoma Cohort | Includes adult patients diagnosed with metastatic malignant melanoma and treated between November 2022 and December 2024. Systemic therapies included immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab), BRAF/MEK targeted agents (dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib), and chemotherapy (dacarbazine or temozolomide). Treatment was delivered per routine clinical practice; no experimental assignment occurred. Receives: Drug: Systemic Therapy for Metastatic Melanoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from initiation of systemic therapy to the earliest date of radiologically or clinically documented disease progression or death from any cause. Disease progression will be determined based on imaging studies or clinical evaluations recorded in medical files. Patients alive without documented progression at last follow-up will be censored.
Measured: From treatment initiation to disease progression or death, up to December 2024.
Secondary outcomes (6)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from systemic therapy initiation to death from any cause. Patients alive at last follow-up will be censored.
Measured: From treatment initiation to death or last follow-up, up to December 2024.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to radiologic or clinical assessments documented in medical records. Responses will be determined by follow-up imaging or clinical examination.
Measured: From treatment initiation to best documented response, within November 2022 - December 2024.
Incidence of Dermatologic Adverse Events
Incidence and grade of dermatologic adverse events, reported as number of patients (n) and percentage (%), including rash, pruritus, vitiligo, mucositis, and other toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From treatment initiation to last follow-up, up to December 2024.
Treatment Discontinuation Due to Toxicity
Proportion of patients who discontinued or interrupted systemic therapy due to treatment-related adverse events. Reasons and timing for discontinuation will be recorded based on medical records and categorized according to therapy type (immune checkpoint inhibitors, targeted therapy, or chemotherapy).
Measured: From treatment initiation to treatment discontinuation or last follow-up, up to December 2024.
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as their best overall documented response during systemic therapy. Determined through radiologic or clinical assessment.
Measured: From treatment initiation to best documented response assessment, within November 2022 - December 2024.
Impact of Dermatologic Adverse Events on Progression-Free Survival
The association between dermatologic adverse events and PFS, expressed as a hazard ratio (HR) derived from survival analysis models.
Measured: From treatment initiation to progression or last follow-up, up to December 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start15 Nov 2022
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256184
- Sponsor's protocol ID
- AEŞH-BADEK-2025-0153
- Other IDs
- AEŞH-BADEK-2025-0153
- Acronym
- MEL-CARE
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical, Pathologic, and Molecular Determinants of Prognosis and Treatment Response in Patients With Metastatic Malignant Melanoma: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07256184
- Acronym / sponsor ID
- MEL-CARE / AEŞH-BADEK-2025-0153
- Conditions
- Metastatic Malignant Melanoma
- Keywords
- melanoma, metastatic melanoma, prognosis, treatment response, immunotherapy, targeted therapy, BRAF mutation, PD-1 inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 1 Dec 2025 (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.
This multicenter, retrospective observational study aims to identify clinical, pathological, and molecular factors associated with prognosis and treatment response in patients with metastatic malignant melanoma. Medical records of adult patients diagnosed and treated between November 2022 and December 2024 at participating oncology centers in Türkiye were reviewed.
Data collected include demographic features, disease characteristics, histopathologic findings, treatment modalities (immune checkpoint inhibitors, targeted therapy, or chemotherapy), and dermatologic adverse events. These variables will be analyzed in relation to survival outcomes to provide real-world evidence supporting personalized management strategies in metastatic melanoma.
Detailed description
This multicenter retrospective cohort study evaluates clinical, pathological, and molecular factors that may influence prognosis and treatment response in patients with metastatic malignant melanoma treated between November 2022 and December 2024. The study focuses on routinely collected real-world data, including demographic characteristics, disease features, systemic treatment regimens, and dermatologic adverse events.
The primary analytical objectives are to assess associations between baseline variables and treatment outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Objective Response Rate (ORR). Dermatologic and systemic toxicities graded using CTCAE v5.0 will also be explored for their potential impact on treatment continuity and outcomes. The study uses descriptive statistics, survival analyses, and Cox regression models. No experimental interventions are assigned, and all treatments were delivered as part of routine clinical practice.
This description provides an overview of study intent and analytic framework without duplicating detailed eligibility criteria or outcome definitions recorded in other submission fields.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicenter Metastatic Melanoma Cohort | – | Drug: Systemic Therapy for Metastatic MelanomaIncludes adult patients diagnosed with metastatic malignant melanoma and treated between November 2022 and December 2024. Systemic therapies included immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab), BRAF/MEK targeted agents (dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib), and chemotherapy (dacarbazine or temozolomide). Treatment was delivered per routine clinical practice; no experimental assignment occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with metastatic malignant melanoma treated with standard systemic therapy, including immune checkpoint inhibitors, BRAF/MEK inhibitors, or chemotherapy. Data were extracted retrospectively from electronic medical records across multiple oncology centers in Türkiye.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Histologically or cytologically confirmed metastatic malignant melanoma
- Received ≥1 line of systemic therapy
- Complete baseline and follow-up data
- At least one measurable lesion or clinical response assessment
Key exclusion criteria (5 listed)
- Incomplete clinical or pathological data
- Uncertain or revised diagnosis
- Metastasis developing outside the inclusion window
- Another primary malignancy (except allowed types)
- Lost to follow-up before first response assessment
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 |
|---|---|---|
| Systemic Therapy for Metastatic MelanomaStandard systemic treatments administered for metastatic malignant melanoma, including immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab), targeted therapy (dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib), and chemotherapy (dacarbazine or temozolomide regimens). All treatments were provided as part of routine institutional clinical practice. No investigational or randomized assignment was performed. Treatment information was collected retrospectively from medical records for evaluation of prognostic and treatment-response outcomes. | Drug | Multicenter Metastatic Melanoma Cohort |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From treatment initiation to disease progression or death, up to December 2024.
Progression-Free Survival (PFS) is defined as the time from initiation of systemic therapy to the earliest date of radiologically or clinically documented disease progression or death from any cause. Disease progression will be determined based on imaging studies or clinical evaluations recorded in medical files. Patients alive without documented progression at last follow-up will be censored.
6 secondary outcomes
Overall Survival (OS)
Time frame: From treatment initiation to death or last follow-up, up to December 2024.
Objective Response Rate (ORR)
Time frame: From treatment initiation to best documented response, within November 2022 - December 2024.
Incidence of Dermatologic Adverse Events
Time frame: From treatment initiation to last follow-up, up to December 2024.
Treatment Discontinuation Due to Toxicity
Time frame: From treatment initiation to treatment discontinuation or last follow-up, up to December 2024.
Disease Control Rate (DCR)
Time frame: From treatment initiation to best documented response assessment, within November 2022 - December 2024.
Impact of Dermatologic Adverse Events on Progression-Free Survival
Time frame: From treatment initiation to progression or last follow-up, up to December 2024.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Malignant Melanoma, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From treatment initiation to disease progression or death, up to December 2024.). 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 15 Dec 2025.