Prognostic and Treatment-Response Factors in Metastatic Melanoma: Multi-Center Analysis (MEL-CARE)

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Malignant Melanoma
• Intervention / Treatment: Drug: Systemic Therapy for 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 Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06210
      • Ankara Etlik City Hospital
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye)
      • Gazi University, Medical Oncology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Systemic Therapy for Metastatic Melanoma; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From treatment initiation to disease progression or death, up to December 2024.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	From treatment initiation to progression or last follow-up, up to December 2024.

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: immunotherapy; prognosis; adverse events; targeted therapy; melanoma; BRAF mutation; metastatic melanoma; treatment response; PD-1 inhibitors; dermatologic toxicity; CTLA-4 inhibitors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: AEŞH-BADEK-2025-0153 (Other Identifier: Ankara Etlik City Hospital Scientific Research and Evaluation Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No