Cutaneous Squamous Cell Carcinoma (CSCC)D-TECTNCT07684066
D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab
An observational study of Cutaneous Squamous Cell Carcinoma (CSCC) and Advanced Cutaneous Squamous Cell Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Pretreatment D-dimer status
- Type of treatment
- Injection or infusion
- How many people
- 116 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 1 Aug 2026to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
Germany14 sites
University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
Bielefeld, 33647
Selma Ugurel, MD, +49 (0)521 9438801, selma.ugurel@klinikumbielefeld.de
Selma Ugurel, MD
Klinikum Bremerhaven Reinkenheide
Bremerhaven, 27574
Michael M. Sachse, MD, +49 (0)471 2993700, Michael.Sachse@klinikum-bremerhaven.de
Michael M. Sachse, MD
Elbe Klinikum Buxtehude
Buxtehude, 21614
Kai-Martin Thoms, MD, +49 (0)4161 7036250, kai-martin.thoms@elbekliniken.de
Kai-Martin Thoms, MD
University Medical Center Erlangen
Erlangen, 91054
Markus V. Heppt, MD, PhD, MHBA, +49 (0)9131 8533165, onkstudienzentrale.DE@uk-erlangen.de
Markus V. Heppt, MD, PhD, MHBA
University Medical Center Göttingen
Göttingen, 37075
Katharina Amschler, MD, +49 (0)551 3968082, katharina.amschler@med.uni-goettingen.de
Katharina Amschler, MD
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Glenn Geidel, MD, MSc, +49 (0)40 741070743, g.geidel@uke.de
Glenn Geidel, MD, MSc
Hannover Medical School
Hanover, 30625
Imke von Wasielewski, MD, +49 (0)5115320, vonWasielewski.Imke@mh-hannover.de
Imke von Wasielewski, MD
University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, 24105
Katharina Kähler, MD, +49 (0)431 50021131, Katharina.Kaehler@uksh.de
Katharina Kähler, MD
University Medical Center Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Dagmar von Bubnoff, MD, +49 (0)451 50041501, DagmarAngela.vonbubnoff@uksh.de
Dagmar von Bubnoff, MD
University Medical Center Mainz
Mainz, 55131
Henner Stege, MD, +49 (0)6131 172919, Henner.Stege@unimedizin-mainz.de
Henner Stege, MD
University Medical Center Mannheim
Mannheim, 68167
Jochen Utikal, MD, +49 (0)621 3834461, jochen.utikal@umm.de
Jochen Utikal, MD
Johannes Wesling Klinikum Minden
Minden, 32429
Ralf Gutzmer, MD, +49 (0)571 7904501, dermatologie-minden@muehlenkreiskliniken.de
Ralf Gutzmer, MD
University Medical Center Rostock
Rostock, 18057
Markus Thieme, MD, +49 (0) 381 494 9789, Markus.Thieme@med.uni-rostock.de
Markus Thieme, MD
University Medical Center Tübingen
Tübingen, 72076
Ulrike Leiter, MD, +49 (0)7071 2984555, ulrike.leiter@med.uni-tuebingen.de
Ulrike Leiter, MD
Austria1 site
University Medical Center Salzburg
Salzburg, 5020
Matthias Brandlmaier, MD, PhD, MSc, +43 (0) 57255 24601, m.brandlmaier@salk.at
Matthias Brandlmaier, MD, PhD, MSc
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
- Being tested
- Pretreatment D-dimer status
- Keywords
- CSCC, Cutaneous Squamous Cell Carcinoma, D-Dimer, Cemiplimab, PD-1 inhibitor, immunotherapy, biomarker, disease control, coagulation, real-word evidence
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretreatment D-dimer statusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pretreatment D-dimer status | |
| 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. Receives: Other: Pretreatment D-dimer status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of cemiplimab treatment through 6 months
Secondary outcomes (5)
Objective Response Rate
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.
Measured: From start of cemiplimab treatment through 24 months
Progression-Free Survival
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.
Measured: From start of cemiplimab treatment through 24 months
Overall Survival
Overall survival is defined as the time from initiation of cemiplimab treatment to death from any cause.
Measured: From start of cemiplimab treatment through 24 months
Thromboembolic Events During Follow-up
Incidence of venous or arterial thromboembolic events documented during follow-up and evaluated in relation to pretreatment D-dimer levels.
Measured: From start of cemiplimab treatment through 24 months
Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
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.
Measured: From start of cemiplimab treatment through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma (CSCC)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Geidel, MD, MSc, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684066
- Sponsor's protocol ID
- D-TECT
- Other IDs
- DRKS00040746
- Acronym
- D-TECT
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07684066
- Acronym / sponsor ID
- D-TECT / D-TECT
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
- Keywords
- CSCC, Cutaneous Squamous Cell Carcinoma, D-Dimer, Cemiplimab, PD-1 inhibitor, immunotherapy, biomarker, disease control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High pretreatment D-dimer | – | Other: Pretreatment D-dimer statusPatients 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 | – | Other: Pretreatment D-dimer statusPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pretreatment D-dimer statusPretreatment 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. | Other | High pretreatment D-dimer, Low pretreatment D-dimer |
Primary outcome
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
Time frame: 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.
5 secondary outcomes
Objective Response Rate
Time frame: From start of cemiplimab treatment through 24 months
Progression-Free Survival
Time frame: From start of cemiplimab treatment through 24 months
Overall Survival
Time frame: From start of cemiplimab treatment through 24 months
Thromboembolic Events During Follow-up
Time frame: From start of cemiplimab treatment through 24 months
Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
Time frame: From start of cemiplimab treatment through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Geidel, MD, MSc principal investigator
Universitätsklinikum Hamburg-Eppendorf
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma (CSCC) and Advanced Cutaneous Squamous Cell Carcinoma, run by Universitätsklinikum Hamburg-Eppendorf at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenn Geidel, MD, MSc (+49 (0)40 7410 70743, g.geidel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment (time frame: From start of cemiplimab treatment through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.