Recruiting NCT07302607
Predictive Factors of Complete Response to Immunotherapy in Metastatic Melanoma: a Single-center Retrospective Study Between 2013 and 2021
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stage III Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Response Evaluation Criteria in Solid Tumors [Time frame: 1 hour after consultation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Service de dermatologie - Réanimation - CHU de Strasbourg - France — Strasbourg
Identifiers
NCT: NCT07302607 · 9453