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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Cutaneous Squamous Cell Carcinoma; Metastatic Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma (CSCC)
• Intervention / Treatment: Other: Pretreatment D-dimer status

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 Type: Observational
• Enrollment (Estimated): 116

Contacts and Locations

• Study Contact: Name: Glenn Geidel, MD, MSc; Phone Number: +49 (0)40 7410 70743; Email: g.geidel@uke.de

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • University Medical Center Salzburg
    • Contact: Matthias Brandlmaier, MD, PhD, MSc; Phone Number: +43 (0) 57255 24601; Email: m.brandlmaier@salk.at
    • Principal Investigator: Matthias Brandlmaier, MD, PhD, MSc
• Germany
  • Bielefeld, Germany, 33647
    • University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
    • Contact: Selma Ugurel, MD; Phone Number: +49 (0)521 9438801; Email: selma.ugurel@klinikumbielefeld.de
    • Principal Investigator: Selma Ugurel, MD
  • Bremerhaven, Germany, 27574
    • Klinikum Bremerhaven Reinkenheide
    • Contact: Michael M. Sachse, MD; Phone Number: +49 (0)471 2993700; Email: Michael.Sachse@klinikum-bremerhaven.de
    • Principal Investigator: Michael M. Sachse, MD
  • Buxtehude, Germany, 21614
    • Elbe Klinikum Buxtehude
    • Contact: Kai-Martin Thoms, MD; Phone Number: +49 (0)4161 7036250; Email: kai-martin.thoms@elbekliniken.de
    • Principal Investigator: Kai-Martin Thoms, MD
  • Erlangen, Germany, 91054
    • University Medical Center Erlangen
    • Contact: Markus V. Heppt, MD, PhD, MHBA; Phone Number: +49 (0)9131 8533165; Email: onkstudienzentrale.DE@uk-erlangen.de
    • Principal Investigator: Markus V. Heppt, MD, PhD, MHBA
  • Göttingen, Germany, 37075
    • University Medical Center Göttingen
    • Contact: Katharina Amschler, MD; Phone Number: +49 (0)551 3968082; Email: katharina.amschler@med.uni-goettingen.de
    • Principal Investigator: Katharina Amschler, MD
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf
    • Contact: Glenn Geidel, MD, MSc; Phone Number: +49 (0)40 741070743; Email: g.geidel@uke.de
    • Principal Investigator: Glenn Geidel, MD, MSc
  • Hanover, Germany, 30625
    • Hannover Medical School
    • Contact: Imke von Wasielewski, MD; Phone Number: +49 (0)5115320; Email: vonWasielewski.Imke@mh-hannover.de
    • Principal Investigator: Imke von Wasielewski, MD
  • Lübeck, Germany, 23538
    • University Medical Center Schleswig-Holstein, Campus Lübeck
    • Contact: Dagmar von Bubnoff, MD; Phone Number: +49 (0)451 50041501; Email: DagmarAngela.vonbubnoff@uksh.de
    • Principal Investigator: Dagmar von Bubnoff, MD
  • Mainz, Germany, 55131
    • University Medical Center Mainz
    • Contact: Henner Stege, MD; Phone Number: +49 (0)6131 172919; Email: Henner.Stege@unimedizin-mainz.de
    • Principal Investigator: Henner Stege, MD
  • Mannheim, Germany, 68167
    • University Medical Center Mannheim
    • Principal Investigator: Jochen Utikal, MD
    • Contact: Jochen Utikal, MD; Phone Number: +49 (0)621 3834461; Email: jochen.utikal@umm.de
  • Minden, Germany, 32429
    • Johannes Wesling Klinikum Minden
    • Contact: Ralf Gutzmer, MD; Phone Number: +49 (0)571 7904501; Email: dermatologie-minden@muehlenkreiskliniken.de
    • Principal Investigator: Ralf Gutzmer, MD
  • Rostock, Germany, 18057
    • University Medical Center Rostock
    • Contact: Markus Thieme, MD; Phone Number: +49 (0) 381 494 9789; Email: Markus.Thieme@med.uni-rostock.de
    • Principal Investigator: Markus Thieme, MD
  • Tübingen, Germany, 72076
    • University Medical Center Tübingen
    • Principal Investigator: Ulrike Leiter, MD
    • Contact: Ulrike Leiter, MD; Phone Number: +49 (0)7071 2984555; Email: ulrike.leiter@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	From start of cemiplimab treatment through 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event	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	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	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Glenn Geidel, MD, MSc, Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; biomarker; D-Dimer; PD-1 inhibitor; coagulation; Cutaneous Squamous Cell Carcinoma; Cemiplimab; CSCC; disease control; real-word evidence
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: D-TECT; DRKS00040746 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No