Factors linked to complete responses to immunotherapy in metastatic melanoma

Predictive Factors of Complete Response to Immunotherapy in Metastatic Melanoma: a Single-center Retrospective Study Between 2013 and 2021

This project looks back at records to see which adults with unresectable stage III or IV melanoma had complete, lasting responses to anti‑PD‑1 and/or anti‑CTLA‑4 immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 221 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Strasbourg, France (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Strasbourg)
• Trial ID: NCT07302607 on ClinicalTrials.gov

What this trial studies

This is a single‑center retrospective review of patients with unresectable stage III or stage IV melanoma treated with curative‑intent anti‑PD‑1 and/or anti‑CTLA‑4 immunotherapy at the Strasbourg University Hospitals between January 1, 2013 and December 31, 2021. Investigators will use medical records from the Dermatology Department to identify clinical, pathological, and treatment features associated with complete and sustained responses. Patients with primary choroidal melanoma, those receiving adjuvant immunotherapy, those treated outside the dermatology department, or with less than three months of follow‑up are excluded. The goal is to find additional predictive factors not yet reported in the literature while building on previously recognized markers.

Who should consider this trial

Good fit: Adults (≥18 years) with unresectable stage III or stage IV melanoma who received curative‑intent anti‑PD‑1 and/or anti‑CTLA‑4 immunotherapy and were treated and followed in the Dermatology Department of Strasbourg University Hospitals between 2013 and 2021 are the intended group.

Not a fit: Patients with primary choroidal melanoma, those who received immunotherapy as adjuvant treatment, those treated or followed outside the Strasbourg Dermatology Department, or those with under three months of follow‑up are not included and therefore will not directly benefit from this study's data.

Why it matters

Potential benefit: If successful, the findings could help clinicians better predict which patients with unresectable stage III/IV melanoma are most likely to achieve a complete and lasting response to anti‑PD‑1 and/or anti‑CTLA‑4 therapy.

How similar studies have performed: Previous retrospective and prospective studies have already identified several predictors of immunotherapy response in metastatic melanoma, and this single‑center review aims to extend those findings by searching for additional, less‑studied factors.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years;
* Unresectable stage III or stage IV melanoma according to the AJCC classification - 8th edition;
* Curative immunotherapy treatment (anti-PD-1 and/or anti-CTLA-4);
* Treatment and follow-up at the Dermatology Department of the Strasbourg University Hospitals;
* Immunotherapy initiated between January 1, 2013, and December 31, 2021.

Exclusion Criteria:

* Primary choroidal melanoma;
* Adjuvant-intent immunotherapy;
* Less than 3 months of follow-up after the start of immunotherapy;
* Change of treatment before the first reassessment;
* Treatment and follow-up at a department other than the Dermatology Department of the Strasbourg University Hospitals.

Where this trial is running

Strasbourg

• Service de dermatologie - Réanimation - CHU de Strasbourg - France — Strasbourg, France (Recruiting)

Study contacts

• Study coordinator: Cédric LENORMAND, MD

Conditions Stage III Melanoma; Immunotherapy in Metastatic Melanoma; Metastatic melanoma