D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab (D-TECT)
21. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
116
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Glenn Geidel, MD, MSc
- Telefonnummer: +49 (0)40 7410 70743
- E-Mail: g.geidel@uke.de
Studienorte
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Bielefeld, Deutschland, 33647
- University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
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Kontakt:
- Selma Ugurel, MD
- Telefonnummer: +49 (0)521 9438801
- E-Mail: selma.ugurel@klinikumbielefeld.de
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Hauptermittler:
- Selma Ugurel, MD
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Bremerhaven, Deutschland, 27574
- Klinikum Bremerhaven Reinkenheide
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Kontakt:
- Michael M. Sachse, MD
- Telefonnummer: +49 (0)471 2993700
- E-Mail: Michael.Sachse@klinikum-bremerhaven.de
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Hauptermittler:
- Michael M. Sachse, MD
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Buxtehude, Deutschland, 21614
- Elbe Klinikum Buxtehude
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Kontakt:
- Kai-Martin Thoms, MD
- Telefonnummer: +49 (0)4161 7036250
- E-Mail: kai-martin.thoms@elbekliniken.de
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Hauptermittler:
- Kai-Martin Thoms, MD
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Erlangen, Deutschland, 91054
- University Medical Center Erlangen
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Kontakt:
- Markus V. Heppt, MD, PhD, MHBA
- Telefonnummer: +49 (0)9131 8533165
- E-Mail: onkstudienzentrale.DE@uk-erlangen.de
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Hauptermittler:
- Markus V. Heppt, MD, PhD, MHBA
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Göttingen, Deutschland, 37075
- University Medical Center Göttingen
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Kontakt:
- Katharina Amschler, MD
- Telefonnummer: +49 (0)551 3968082
- E-Mail: katharina.amschler@med.uni-goettingen.de
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Hauptermittler:
- Katharina Amschler, MD
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Hamburg, Deutschland, 20246
- University Medical Center Hamburg-Eppendorf
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Kontakt:
- Glenn Geidel, MD, MSc
- Telefonnummer: +49 (0)40 741070743
- E-Mail: g.geidel@uke.de
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Hauptermittler:
- Glenn Geidel, MD, MSc
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Hanover, Deutschland, 30625
- Hannover Medical School
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Kontakt:
- Imke von Wasielewski, MD
- Telefonnummer: +49 (0)5115320
- E-Mail: vonWasielewski.Imke@mh-hannover.de
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Hauptermittler:
- Imke von Wasielewski, MD
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Kiel, Deutschland, 24105
- University Medical Center Schleswig-Holstein, Campus Kiel
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Hauptermittler:
- Katharina Kähler, MD
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Kontakt:
- Katharina Kähler, MD
- Telefonnummer: +49 (0)431 50021131
- E-Mail: Katharina.Kaehler@uksh.de
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Lübeck, Deutschland, 23538
- University Medical Center Schleswig-Holstein, Campus Lübeck
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Kontakt:
- Dagmar von Bubnoff, MD
- Telefonnummer: +49 (0)451 50041501
- E-Mail: DagmarAngela.vonbubnoff@uksh.de
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Hauptermittler:
- Dagmar von Bubnoff, MD
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Mainz, Deutschland, 55131
- University Medical Center Mainz
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Kontakt:
- Henner Stege, MD
- Telefonnummer: +49 (0)6131 172919
- E-Mail: Henner.Stege@unimedizin-mainz.de
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Hauptermittler:
- Henner Stege, MD
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Mannheim, Deutschland, 68167
- University Medical Center Mannheim
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Hauptermittler:
- Jochen Utikal, MD
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Kontakt:
- Jochen Utikal, MD
- Telefonnummer: +49 (0)621 3834461
- E-Mail: jochen.utikal@umm.de
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Minden, Deutschland, 32429
- Johannes Wesling Klinikum Minden
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Kontakt:
- Ralf Gutzmer, MD
- Telefonnummer: +49 (0)571 7904501
- E-Mail: dermatologie-minden@muehlenkreiskliniken.de
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Hauptermittler:
- Ralf Gutzmer, MD
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Rostock, Deutschland, 18057
- University Medical Center Rostock
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Kontakt:
- Markus Thieme, MD
- Telefonnummer: +49 (0) 381 494 9789
- E-Mail: Markus.Thieme@med.uni-rostock.de
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Hauptermittler:
- Markus Thieme, MD
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Tübingen, Deutschland, 72076
- University Medical Center Tübingen
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Hauptermittler:
- Ulrike Leiter, MD
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Kontakt:
- Ulrike Leiter, MD
- Telefonnummer: +49 (0)7071 2984555
- E-Mail: ulrike.leiter@med.uni-tuebingen.de
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Salzburg, Österreich, 5020
- University Medical Center Salzburg
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Kontakt:
- Matthias Brandlmaier, MD, PhD, MSc
- Telefonnummer: +43 (0) 57255 24601
- E-Mail: m.brandlmaier@salk.at
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Hauptermittler:
- Matthias Brandlmaier, MD, PhD, MSc
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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.
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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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Objective Response Rate
Zeitfenster: 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
|
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Progression-Free Survival
Zeitfenster: 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
|
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Overall Survival
Zeitfenster: 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
Zeitfenster: 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.
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From start of cemiplimab treatment through 24 months
|
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Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
Zeitfenster: From start of cemiplimab treatment through 24 months
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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.
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From start of cemiplimab treatment through 24 months
|
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Association of Pretreatment D-dimer Levels With Clinical Outcomes in Multivariable Models
Zeitfenster: From start of cemiplimab treatment through 24 months
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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.
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From start of cemiplimab treatment through 24 months
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Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
Zeitfenster: Baseline through 24 months
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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.
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Baseline through 24 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Glenn Geidel, MD, MSc, Universitätsklinikum Hamburg-Eppendorf
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. August 2026
Primärer Abschluss (Geschätzt)
31. Juli 2028
Studienabschluss (Geschätzt)
31. März 2030
Studienanmeldedaten
Zuerst eingereicht
28. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Juni 2026
Zuerst gepostet (Tatsächlich)
6. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- D-TECT
- DRKS00040746 (Registrierungskennung: German Clinical Trials Register)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .