D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab
D-TECT
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
2 other identifiers
observational
116
2 countries
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
July 22, 2026
July 1, 2026
2 years
June 28, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
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
Secondary Outcomes (5)
Objective Response Rate
From start of cemiplimab treatment through 24 months
Progression-Free Survival
From start of cemiplimab treatment through 24 months
Overall Survival
From start of cemiplimab treatment through 24 months
Thromboembolic Events During Follow-up
From start of cemiplimab treatment through 24 months
Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
From start of cemiplimab treatment through 6 months
Other Outcomes (3)
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
From start of cemiplimab treatment through 24 months
Association of Pretreatment D-dimer Levels With Clinical Outcomes in Multivariable Models
From start of cemiplimab treatment through 24 months
Exploratory Analysis of Assay-Related Heterogeneity in D-dimer Measurements
Baseline through 24 months
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University Medical Center Salzburg
Salzburg, 5020, Austria
University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
Bielefeld, 33647, Germany
Klinikum Bremerhaven Reinkenheide
Bremerhaven, 27574, Germany
Elbe Klinikum Buxtehude
Buxtehude, 21614, Germany
University Medical Center Erlangen
Erlangen, 91054, Germany
University Medical Center Göttingen
Göttingen, 37075, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Hannover Medical School
Hanover, 30625, Germany
University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
University Medical Center Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
University Medical Center Mainz
Mainz, 55131, Germany
University Medical Center Mannheim
Mannheim, 68167, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
University Medical Center Rostock
Rostock, 18057, Germany
University Medical Center Tübingen
Tübingen, 72076, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn Geidel, MD, MSc
Universitätsklinikum Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2026
First Posted
July 6, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
March 31, 2030
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.