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

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

116

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Glenn Geidel, MD, MSc
  • Numero di telefono: +49 (0)40 7410 70743
  • Email: g.geidel@uke.de

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigatori

  • Investigatore principale: Glenn Geidel, MD, MSc, Universitätsklinikum Hamburg-Eppendorf

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 luglio 2028

Completamento dello studio (Stimato)

31 marzo 2030

Date di iscrizione allo studio

Primo inviato

28 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D-TECT
  • DRKS00040746 (Identificatore di registro: German Clinical Trials Register)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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