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

Ankara Etlik City Hospital

Status: Completed

Conditions: Metastatic Malignant Melanoma

Treatments: Drug: Systemic Therapy for Metastatic Melanoma

Study type: Observational

Funder types: Other

Identifiers

NCT07256184

AEŞH-BADEK-2025-0153 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

232 participants in 1 patient group

Multicenter Metastatic Melanoma Cohort

Description:

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.

Treatment:

Drug: Systemic Therapy for Metastatic Melanoma