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

Although impressive progress has been made with this new therapeutic strategy, only a proportion of patients achieve a complete and sustained response. Studies have already identified predictive factors of treatment response that are now widely recognized. In this study, the investigators aim to identify other response factors not yet evaluated in the literature.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de dermatologie - Réanimation - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Cédric LENORMAND, MD

CONTACT

[email protected]

33 3 88 11 66 27

Cédric LENORMAND, MD

PRINCIPAL_INVESTIGATOR

Sixtine COLBACH, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Response Evaluation Criteria in Solid Tumors

Time frame: 1 hour after consultation

Response criteria

Based on assessment of target and non-target lesions, the disease can be classified as 8:

complete response (CR):

requires all of:

disappearance of all target and non-target lesions

pathological lymph nodes must have reduced to <10 mm in short axis

no new lesions

partial response (PR):

requires all of:

at least 30% decrease in SOD of target lesions compared to baseline sum diameters (BSD)

non-progressive disease of non-target lesions

no new lesions

progressive disease (PD):

either one of:

any new lesions

at least 20% relative and 5 mm absolute increase of SOD of target lesions compared to smallest SOD ever recorded for the patient

stable disease (SD):

not meeting criteria for PD or PR

Study contacts

Contact information is provided by the study sponsor or research team.

Cédric LENORMAND, MD

CONTACT

[email protected]

33 3 88 11 66 27

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: IMM

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 24, 2025
Registry last updated: Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed