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

NCT07684066 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 116

Last updated 2026-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)
  • Advanced Cutaneous Squamous Cell Carcinoma
  • Metastatic Cutaneous Squamous Cell Carcinoma

Interventions

OTHER

Pretreatment D-dimer status

Pretreatment D-dimer status is defined using a single D-dimer measurement obtained in routine clinical laboratory testing within 7 days before the first cemiplimab dose up to the day of first administration before infusion. D-dimer status is not used to assign treatment and does not mandate any study-specific diagnostic or therapeutic intervention.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Glenn Geidel, MD, MSc · Universitätsklinikum Hamburg-Eppendorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-07-31
Completion
2030-03-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684066 on ClinicalTrials.gov