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D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab

Not Yet RecruitingN/A

Sponsor: Universitätsklinikum Hamburg-Eppendorf

Conditions: Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma

Interventions: Pretreatment D-dimer status

Countries: Austria, Germany

D-TECT is a prospective, multicenter, non-interventional observational study investigating whether pretreatment D-dimer levels predict disease control in patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care. D-dimers are routinely available laboratory markers related to activation of the coagulation system. Previous single-center data suggest that elevated pretreatment D-dimer levels may be associated with poorer disease control under cemiplimab. In D-TECT, a single pretreatment D-dimer value and prospectively collected routine clinical follow-up data will be analyzed to validate this association in a multicenter real-world setting. No study-specific treatment decisions, imaging procedures, or additional blood draws are mandated by the study.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
* Planned initiation of systemic treatment with cemiplimab as part of routine clinical care
* Pretreatment D-dimer measurement performed within 7 days before initiation of cemiplimab treatment up to the day of first administration before infusion
* Age 18 years or older at the time of consent
* ECOG performance status 0 to 2
* Written informed consent for study participation and pseudonymized collection and analysis of clinical and laboratory data

Exclusion Criteria:

* Prior treatment with immune checkpoint inhibitors in curative or palliative intent for cutaneous squamous cell carcinoma
* Concurrent second malignancy requiring systemic treatment, such as chemotherapy, immunotherapy, or targeted therapy
* Clinically unstable comorbidity, including NYHA class III-IV heart failure or active systemic infection
* Acute symptomatic thrombosis or pulmonary embolism within 4 weeks before the pretreatment D-dimer measurement
* Incidental asymptomatic thromboembolic events detected during clinical diagnostic work-up or following an elevated D-dimer result are not exclusion criteria and will be documented
* Physician-estimated life expectancy of less than 3 months or severe non-tumor-related comorbidity likely to preclude assessment of the clinical course within the first 6 months
* Lack of capacity to consent or legal guardianship without valid legal representation

Locations (15)

Salzburg, Austria
Bielefeld, Germany
Bremerhaven, Germany
Buxtehude, Germany
Erlangen, Germany
Göttingen, Germany
Hamburg, Germany
Hanover, Germany
Kiel, Germany
Lübeck, Germany
Mainz, Germany
Mannheim, Germany
Minden, Germany
Rostock, Germany
Tübingen, Germany