Clinical trial · Observational
D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab
D-TECT: Prospective Multicenter Evaluation of Pretreatment D-dimer Levels as a Predictor of Disease Control in Advanced Cutaneous Squamous Cell Carcinoma Treated With Cemiplimab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Cutaneous Squamous Cell Carcinoma (CSCC) | Skin Squamous Cell Carcinoma | ALIAS | 0.85 |
| Metastatic Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pretreatment D-dimer status | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- High pretreatment D-dimer
- description
- Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level above the prespecified cutoff of 0.91 mg/L FEU.
- interventionNames
- Other: Pretreatment D-dimer status
- label
- Low pretreatment D-dimer
- description
- Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level at or below the prespecified cutoff of 0.91 mg/L FEU.
- interventionNames
- Other: Pretreatment D-dimer status
Primary outcomes (1)
- measure
- Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
- timeFrame
- From start of cemiplimab treatment through 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available