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

21 de julio de 2026 actualizado por: Universitätsklinikum Hamburg-Eppendorf

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

116

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Glenn Geidel, MD, MSc
  • Número de teléfono: +49 (0)40 7410 70743
  • Correo electrónico: g.geidel@uke.de

Ubicaciones de estudio

  • Alemania
      • Bielefeld, Alemania, 33647
        • University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
        • Contacto:
        • Investigador principal:
          • Selma Ugurel, MD
      • Bremerhaven, Alemania, 27574
        • Klinikum Bremerhaven Reinkenheide
        • Contacto:
        • Investigador principal:
          • Michael M. Sachse, MD
      • Buxtehude, Alemania, 21614
        • Elbe Klinikum Buxtehude
        • Contacto:
        • Investigador principal:
          • Kai-Martin Thoms, MD
      • Erlangen, Alemania, 91054
        • University Medical Center Erlangen
        • Contacto:
        • Investigador principal:
          • Markus V. Heppt, MD, PhD, MHBA
      • Göttingen, Alemania, 37075
        • University Medical Center Göttingen
        • Contacto:
        • Investigador principal:
          • Katharina Amschler, MD
      • Hamburg, Alemania, 20246
        • University Medical Center Hamburg-Eppendorf
        • Contacto:
          • Glenn Geidel, MD, MSc
          • Número de teléfono: +49 (0)40 741070743
          • Correo electrónico: g.geidel@uke.de
        • Investigador principal:
          • Glenn Geidel, MD, MSc
      • Hanover, Alemania, 30625
        • Hannover Medical School
        • Contacto:
        • Investigador principal:
          • Imke von Wasielewski, MD
      • Kiel, Alemania, 24105
        • University Medical Center Schleswig-Holstein, Campus Kiel
        • Investigador principal:
          • Katharina Kähler, MD
        • Contacto:
      • Lübeck, Alemania, 23538
        • University Medical Center Schleswig-Holstein, Campus Lübeck
        • Contacto:
        • Investigador principal:
          • Dagmar von Bubnoff, MD
      • Mainz, Alemania, 55131
        • University Medical Center Mainz
        • Contacto:
        • Investigador principal:
          • Henner Stege, MD
      • Mannheim, Alemania, 68167
        • University Medical Center Mannheim
        • Investigador principal:
          • Jochen Utikal, MD
        • Contacto:
          • Jochen Utikal, MD
          • Número de teléfono: +49 (0)621 3834461
          • Correo electrónico: jochen.utikal@umm.de
      • Minden, Alemania, 32429
      • Rostock, Alemania, 18057
        • University Medical Center Rostock
        • Contacto:
        • Investigador principal:
          • Markus Thieme, MD
      • Tübingen, Alemania, 72076
        • University Medical Center Tübingen
        • Investigador principal:
          • Ulrike Leiter, MD
        • Contacto:
  • Austria
      • Salzburg, Austria, 5020
        • University Medical Center Salzburg
        • Contacto:
          • Matthias Brandlmaier, MD, PhD, MSc
          • Número de teléfono: +43 (0) 57255 24601
          • Correo electrónico: m.brandlmaier@salk.at
        • Investigador principal:
          • Matthias Brandlmaier, MD, PhD, MSc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
High pretreatment D-dimer
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.
Otro: 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.
Low pretreatment D-dimer
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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
Periodo de tiempo: 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.
From start of cemiplimab treatment through 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate
Periodo de tiempo: From start of cemiplimab treatment through 24 months
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.
From start of cemiplimab treatment through 24 months
Progression-Free Survival
Periodo de tiempo: From start of cemiplimab treatment through 24 months
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.
From start of cemiplimab treatment through 24 months
Overall Survival
Periodo de tiempo: From start of cemiplimab treatment through 24 months
Overall survival is defined as the time from initiation of cemiplimab treatment to death from any cause.
From start of cemiplimab treatment through 24 months
Thromboembolic Events During Follow-up
Periodo de tiempo: From start of cemiplimab treatment through 24 months
Incidence of venous or arterial thromboembolic events documented during follow-up and evaluated in relation to pretreatment D-dimer levels.
From start of cemiplimab treatment through 24 months
Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
Periodo de tiempo: From start of cemiplimab treatment through 6 months
Sensitivity, specificity, positive predictive value, and negative predictive value of the prespecified D-dimer cutoff of 0.91 mg/L FEU and of the local laboratory-defined upper limit of normal for disease control within the first 6 months after initiation of cemiplimab.
From start of cemiplimab treatment through 6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
Periodo de tiempo: From start of cemiplimab treatment through 24 months
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.
From start of cemiplimab treatment through 24 months
Association of Pretreatment D-dimer Levels With Clinical Outcomes in Multivariable Models
Periodo de tiempo: From start of cemiplimab treatment through 24 months
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.
From start of cemiplimab treatment through 24 months
Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
Periodo de tiempo: Baseline through 24 months
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.
Baseline through 24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Universitätsklinikum Hamburg-Eppendorf

Investigadores

  • Investigador principal: Glenn Geidel, MD, MSc, Universitätsklinikum Hamburg-Eppendorf

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

31 de julio de 2028

Finalización del estudio (Estimado)

31 de marzo de 2030

Fechas de registro del estudio

Enviado por primera vez

28 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de junio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D-TECT
  • DRKS00040746 (Identificador de registro: German Clinical Trials Register)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No individual participant data will be shared. Study data will be analyzed in pseudonymized form by the coordinating study center. Any further use of study data beyond the present research question would require additional ethical and data protection review and, where applicable, additional consent.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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