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

Официальное название

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

Обзор

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.

Подробное описание

Cutaneous squamous cell carcinoma (cSCC) is one of the most common skin cancers. While most cases can be treated with curative local therapy, a subgroup of patients develops locally advanced or metastatic disease requiring systemic treatment. Cemiplimab, a PD-1 inhibitor, is an established systemic treatment option for advanced cSCC. However, validated routine biomarkers predicting disease control under cemiplimab are lacking.

D-dimers are fibrin degradation products and sensitive markers of coagulation activation. In a prior single-center retrospective analysis, elevated pretreatment D-dimer levels were associated with lower disease control, lower objective response, and shorter progression-free survival in patients with advanced cSCC treated with cemiplimab. D-TECT is designed to prospectively validate this observation in a multicenter real-world cohort.

Eligible patients are adults with histologically confirmed locally advanced or metastatic cSCC for whom cemiplimab treatment is planned as part of routine clinical care. A D-dimer measurement is documented within 7 days before the first cemiplimab dose up to the day of first administration before infusion. Subsequent clinical data, including tumor response, progression, survival, treatment discontinuation, and thromboembolic events, are collected from routine medical records during follow-up.

The primary endpoint is disease control within the first 6 months after initiation of cemiplimab. The primary confirmatory analysis compares disease control between patients with high versus low pretreatment D-dimer values using the prespecified cutoff of 0.91 mg/L FEU derived from the prior single-center study. If the primary analysis is statistically significant, the same primary endpoint will be tested hierarchically using the local laboratory-defined upper limit of normal. Additional analyses include objective response rate, progression-free survival, overall survival, thromboembolic events, diagnostic performance measures of the predefined cutoffs, sensitivity analyses, and exploratory analyses addressing inter-site assay heterogeneity.

Вмешательства

• Другое 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.

Первичные конечные точки

• Disease Control Rate Within the First 6 Months of Cemiplimab Treatment [Срок оценки: From start of cemiplimab treatment through 6 months]

Вторичные конечные точки (5)

• Objective Response Rate [Срок оценки: From start of cemiplimab treatment through 24 months]
• Progression-Free Survival [Срок оценки: From start of cemiplimab treatment through 24 months]
• Overall Survival [Срок оценки: From start of cemiplimab treatment through 24 months]
• Thromboembolic Events During Follow-up [Срок оценки: From start of cemiplimab treatment through 24 months]
• Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control [Срок оценки: From start of cemiplimab treatment through 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 14 центров

• University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe — Bielefeld
• Klinikum Bremerhaven Reinkenheide — Bremerhaven
• Elbe Klinikum Buxtehude — Buxtehude
• University Medical Center Erlangen — Erlangen
• University Medical Center Göttingen — Göttingen
• University Medical Center Hamburg-Eppendorf — Hamburg
• Hannover Medical School — Hanover
• University Medical Center Schleswig-Holstein, Campus Kiel — Kiel
• … и ещё 6 центров

Австрия · 1 центр

• University Medical Center Salzburg — Salzburg

Идентификаторы

NCT: NCT07684066 · D-TECT · DRKS00040746

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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