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.
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
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