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

Starting soon

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

In brief

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.

Key facts

Study ID

NCT07684066

Run by

Universitätsklinikum Hamburg-Eppendorf

People needed

116

Starts

2026-08-01

Expected to finish

2030-03-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Medical Center Salzburg — Salzburg, Austria
• University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe — Bielefeld, Germany
• Klinikum Bremerhaven Reinkenheide — Bremerhaven, Germany
• Elbe Klinikum Buxtehude — Buxtehude, Germany
• University Medical Center Erlangen — Erlangen, Germany
• University Medical Center Göttingen — Göttingen, Germany
• University Medical Center Hamburg-Eppendorf — Hamburg, Germany
• Hannover Medical School — Hanover, Germany
• University Medical Center Schleswig-Holstein, Campus Kiel — Kiel, Germany
• University Medical Center Schleswig-Holstein, Campus Lübeck — Lübeck, Germany
• University Medical Center Mainz — Mainz, Germany
• University Medical Center Mannheim — Mannheim, Germany
• Johannes Wesling Klinikum Minden — Minden, Germany
• University Medical Center Rostock — Rostock, Germany
• University Medical Center Tübingen — Tübingen, Germany

Full record on ClinicalTrials.gov

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