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

NCT07302607 | Recruiting

• 1 other identifier: 9453
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage III Melanoma

Keywords

Stage III Melanoma; Immunotherapy in Metastatic Melanoma; Metastatic melanoma (unresectable stage III and IV)

Outcome Measures

Primary Outcomes (1)

• Response Evaluation Criteria in Solid Tumors

  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

  1 hour after consultation

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 subject with unresectable stage III or stage IV melanoma according to the AJCC classification - 8th edition;

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de dermatologie - Réanimation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

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

Central Study Contacts

Cédric LENORMAND, MD

CONTACT

33 3 88 11 66 27; cedric.lenormand@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: December 11, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)