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

NCT07684066 · tracked via the Priya Life Science Austria tracker

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Phase

Observational

Started

2026-08-01

Last updated

2026-07-22

Condition(s) studied

Cutaneous Squamous Cell Carcinoma (CSCC)Advanced Cutaneous Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Pretreatment D-dimer status

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Disease Control Rate Within the First 6 Months of Cemiplimab Treatment — From start of cemiplimab treatment through 6 months
Disease control rate is defined as the proportion of participants with complete response, partial response, or stable disease according to clinical and/or radiological assessment in routine care within the first 6 months after initiation of cemiplimab. Participants with documented progression, death, or treatment discontinuation due to clinical progression within the first 6 months are considered not to have disease control. Participants without documented progression or death but without evaluable clinical or radiological follow-up assessment within the first 6 months are considered not evaluable for the primary analysis. The primary confirmatory analysis compares disease control between participants with high versus low pretreatment D-dimer levels using the prespecified cutoff of 0.91 mg/L FEU. If statistically significant, the same primary endpoint will be tested hierarchically using the local laboratory-defined upper limit of normal.

Trial sites (15)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07684066 on ClinicalTrials.gov ↗ ← All trials in Austria