D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab (D-TECT)
21 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
116
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Glenn Geidel, MD, MSc
- Numéro de téléphone: +49 (0)40 7410 70743
- E-mail: g.geidel@uke.de
Lieux d'étude
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Bielefeld, Allemagne, 33647
- University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
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Contact:
- Selma Ugurel, MD
- Numéro de téléphone: +49 (0)521 9438801
- E-mail: selma.ugurel@klinikumbielefeld.de
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Chercheur principal:
- Selma Ugurel, MD
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Bremerhaven, Allemagne, 27574
- Klinikum Bremerhaven Reinkenheide
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Contact:
- Michael M. Sachse, MD
- Numéro de téléphone: +49 (0)471 2993700
- E-mail: Michael.Sachse@klinikum-bremerhaven.de
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Chercheur principal:
- Michael M. Sachse, MD
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Buxtehude, Allemagne, 21614
- Elbe Klinikum Buxtehude
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Contact:
- Kai-Martin Thoms, MD
- Numéro de téléphone: +49 (0)4161 7036250
- E-mail: kai-martin.thoms@elbekliniken.de
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Chercheur principal:
- Kai-Martin Thoms, MD
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Erlangen, Allemagne, 91054
- University Medical Center Erlangen
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Contact:
- Markus V. Heppt, MD, PhD, MHBA
- Numéro de téléphone: +49 (0)9131 8533165
- E-mail: onkstudienzentrale.DE@uk-erlangen.de
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Chercheur principal:
- Markus V. Heppt, MD, PhD, MHBA
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Göttingen, Allemagne, 37075
- University Medical Center Göttingen
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Contact:
- Katharina Amschler, MD
- Numéro de téléphone: +49 (0)551 3968082
- E-mail: katharina.amschler@med.uni-goettingen.de
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Chercheur principal:
- Katharina Amschler, MD
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Hamburg, Allemagne, 20246
- University Medical Center Hamburg-Eppendorf
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Contact:
- Glenn Geidel, MD, MSc
- Numéro de téléphone: +49 (0)40 741070743
- E-mail: g.geidel@uke.de
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Chercheur principal:
- Glenn Geidel, MD, MSc
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Hanover, Allemagne, 30625
- Hannover Medical School
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Contact:
- Imke von Wasielewski, MD
- Numéro de téléphone: +49 (0)5115320
- E-mail: vonWasielewski.Imke@mh-hannover.de
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Chercheur principal:
- Imke von Wasielewski, MD
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Kiel, Allemagne, 24105
- University Medical Center Schleswig-Holstein, Campus Kiel
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Chercheur principal:
- Katharina Kähler, MD
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Contact:
- Katharina Kähler, MD
- Numéro de téléphone: +49 (0)431 50021131
- E-mail: Katharina.Kaehler@uksh.de
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Lübeck, Allemagne, 23538
- University Medical Center Schleswig-Holstein, Campus Lübeck
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Contact:
- Dagmar von Bubnoff, MD
- Numéro de téléphone: +49 (0)451 50041501
- E-mail: DagmarAngela.vonbubnoff@uksh.de
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Chercheur principal:
- Dagmar von Bubnoff, MD
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Mainz, Allemagne, 55131
- University Medical Center Mainz
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Contact:
- Henner Stege, MD
- Numéro de téléphone: +49 (0)6131 172919
- E-mail: Henner.Stege@unimedizin-mainz.de
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Chercheur principal:
- Henner Stege, MD
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Mannheim, Allemagne, 68167
- University Medical Center Mannheim
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Chercheur principal:
- Jochen Utikal, MD
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Contact:
- Jochen Utikal, MD
- Numéro de téléphone: +49 (0)621 3834461
- E-mail: jochen.utikal@umm.de
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Minden, Allemagne, 32429
- Johannes Wesling Klinikum Minden
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Contact:
- Ralf Gutzmer, MD
- Numéro de téléphone: +49 (0)571 7904501
- E-mail: dermatologie-minden@muehlenkreiskliniken.de
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Chercheur principal:
- Ralf Gutzmer, MD
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Rostock, Allemagne, 18057
- University Medical Center Rostock
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Contact:
- Markus Thieme, MD
- Numéro de téléphone: +49 (0) 381 494 9789
- E-mail: Markus.Thieme@med.uni-rostock.de
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Chercheur principal:
- Markus Thieme, MD
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Tübingen, Allemagne, 72076
- University Medical Center Tübingen
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Chercheur principal:
- Ulrike Leiter, MD
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Contact:
- Ulrike Leiter, MD
- Numéro de téléphone: +49 (0)7071 2984555
- E-mail: ulrike.leiter@med.uni-tuebingen.de
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Salzburg, L'Autriche, 5020
- University Medical Center Salzburg
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Contact:
- Matthias Brandlmaier, MD, PhD, MSc
- Numéro de téléphone: +43 (0) 57255 24601
- E-mail: m.brandlmaier@salk.at
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Chercheur principal:
- Matthias Brandlmaier, MD, PhD, MSc
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Objective Response Rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
Délai: 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
Délai: 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
|
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Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Glenn Geidel, MD, MSc, Universitätsklinikum Hamburg-Eppendorf
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 juillet 2028
Achèvement de l'étude (Estimé)
31 mars 2030
Dates d'inscription aux études
Première soumission
28 juin 2026
Première soumission répondant aux critères de contrôle qualité
28 juin 2026
Première publication (Réel)
6 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D-TECT
- DRKS00040746 (Identificateur de registre: German Clinical Trials Register)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .