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
Adult patients with histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma for whom systemic treatment with cemiplimab is planned as part of routine clinical care at participating oncology/dermato-oncology centers.
Cohort
Prospective
Pretreatment D-dimer status
Other interventionPretreatment 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.
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
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.
Objective Response Rate
Objective response rate is defined as the proportion of participants with complete response or partial response according to clinical and/or radiological assessment in routine care during follow-up.
Progression-Free Survival
Progression-free survival is defined as the time from initiation of cemiplimab treatment to the first documented disease progression or death from any cause, whichever occurs first.
Overall Survival
Overall survival is defined as the time from initiation of cemiplimab treatment to death from any cause.
Thromboembolic Events During Follow-up
Incidence of venous or arterial thromboembolic events documented during follow-up and evaluated in relation to pretreatment D-dimer levels.
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
Exploratory competing-risk analysis of the cumulative incidence of documented disease progression, treating death without prior documented progression as a competing event. Deaths without prior documented progression will additionally be described by cause of death where available from the medical record.
Association of Pretreatment D-dimer Levels With Clinical Outcomes in Multivariable Models
Exploratory multivariable models evaluating the association between pretreatment D-dimer levels and clinical outcomes while accounting for predefined clinical covariates such as performance status, lactate dehydrogenase, comorbidities, and anticoagulation.
Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
Exploratory evaluation of inter-site heterogeneity in D-dimer assays, measurement units, and local reference ranges. Analyses may include ULN-normalized D-dimer values defined as the quotient of the measured value and the local upper limit of normal.
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