Prognostic and Treatment-Response Factors in Metastatic Melanoma: Multi-Center Analysis

NCT07256184 | Completed

• 1 other identifier: AEŞH-BADEK-2025-0153
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Metastatic Malignant Melanoma

Keywords

melanoma; metastatic melanoma; prognosis; treatment response; immunotherapy; targeted therapy; BRAF mutation; PD-1 inhibitors; CTLA-4 inhibitors; dermatologic toxicity; adverse events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS)

  From treatment initiation to death or last follow-up, up to December 2024.

• Objective Response Rate (ORR)

  From treatment initiation to best documented response, within November 2022 - December 2024.

• Incidence of Dermatologic Adverse Events

  From treatment initiation to last follow-up, up to December 2024.

• Treatment Discontinuation Due to Toxicity

  From treatment initiation to treatment discontinuation or last follow-up, up to December 2024.

• Disease Control Rate (DCR)

  From treatment initiation to best documented response assessment, within November 2022 - December 2024.

Study Arms (1)

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

Interventions

Systemic Therapy for Metastatic Melanoma DRUG

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.

Multicenter Metastatic Melanoma Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Incomplete clinical or pathological data
• Uncertain or revised diagnosis
• Another primary malignancy (except allowed types)
• Lost to follow-up before first response assessment

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (2)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

Gazi University, Medical Oncology Department

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 15, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)