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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07302607

Acronym

IMM

Enrollment

221

Registered

2025-12-24

Start date

2024-12-11

Completion date

2026-01-31

Last updated

2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Melanoma

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Response Evaluation Criteria in Solid Tumors	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

Countries

France

Contacts

Primary ContactCédric LENORMAND, MD

cedric.lenormand@chru-strasbourg.fr33 3 88 11 66 27

Outcome results