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

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.

NCT Number	NCT07684066
Lead Sponsor	Universitätsklinikum Hamburg-Eppendorf
Conditions	Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
Enrollment	116 participants
Start Date	2026-08-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-22