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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Glenn Geidel, MD, MSc
- 电话号码:+49 (0)40 7410 70743
- 邮箱:g.geidel@uke.de
学习地点
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Salzburg、奥地利、5020
- University Medical Center Salzburg
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接触:
- Matthias Brandlmaier, MD, PhD, MSc
- 电话号码:+43 (0) 57255 24601
- 邮箱:m.brandlmaier@salk.at
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首席研究员:
- Matthias Brandlmaier, MD, PhD, MSc
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Bielefeld、德国、33647
- University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
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接触:
- Selma Ugurel, MD
- 电话号码:+49 (0)521 9438801
- 邮箱:selma.ugurel@klinikumbielefeld.de
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首席研究员:
- Selma Ugurel, MD
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Bremerhaven、德国、27574
- Klinikum Bremerhaven Reinkenheide
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接触:
- Michael M. Sachse, MD
- 电话号码:+49 (0)471 2993700
- 邮箱:Michael.Sachse@klinikum-bremerhaven.de
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首席研究员:
- Michael M. Sachse, MD
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Buxtehude、德国、21614
- Elbe Klinikum Buxtehude
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接触:
- Kai-Martin Thoms, MD
- 电话号码:+49 (0)4161 7036250
- 邮箱:kai-martin.thoms@elbekliniken.de
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首席研究员:
- Kai-Martin Thoms, MD
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Erlangen、德国、91054
- University Medical Center Erlangen
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接触:
- Markus V. Heppt, MD, PhD, MHBA
- 电话号码:+49 (0)9131 8533165
- 邮箱:onkstudienzentrale.DE@uk-erlangen.de
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首席研究员:
- Markus V. Heppt, MD, PhD, MHBA
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Göttingen、德国、37075
- University Medical Center Göttingen
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接触:
- Katharina Amschler, MD
- 电话号码:+49 (0)551 3968082
- 邮箱:katharina.amschler@med.uni-goettingen.de
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首席研究员:
- Katharina Amschler, MD
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Hamburg、德国、20246
- University Medical Center Hamburg-Eppendorf
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接触:
- Glenn Geidel, MD, MSc
- 电话号码:+49 (0)40 741070743
- 邮箱:g.geidel@uke.de
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首席研究员:
- Glenn Geidel, MD, MSc
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Hanover、德国、30625
- Hannover Medical School
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接触:
- Imke von Wasielewski, MD
- 电话号码:+49 (0)5115320
- 邮箱:vonWasielewski.Imke@mh-hannover.de
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首席研究员:
- Imke von Wasielewski, MD
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Kiel、德国、24105
- University Medical Center Schleswig-Holstein, Campus Kiel
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首席研究员:
- Katharina Kähler, MD
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接触:
- Katharina Kähler, MD
- 电话号码:+49 (0)431 50021131
- 邮箱:Katharina.Kaehler@uksh.de
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Lübeck、德国、23538
- University Medical Center Schleswig-Holstein, Campus Lübeck
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接触:
- Dagmar von Bubnoff, MD
- 电话号码:+49 (0)451 50041501
- 邮箱:DagmarAngela.vonbubnoff@uksh.de
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首席研究员:
- Dagmar von Bubnoff, MD
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Mainz、德国、55131
- University Medical Center Mainz
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接触:
- Henner Stege, MD
- 电话号码:+49 (0)6131 172919
- 邮箱:Henner.Stege@unimedizin-mainz.de
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首席研究员:
- Henner Stege, MD
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Mannheim、德国、68167
- University Medical Center Mannheim
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首席研究员:
- Jochen Utikal, MD
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接触:
- Jochen Utikal, MD
- 电话号码:+49 (0)621 3834461
- 邮箱:jochen.utikal@umm.de
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Minden、德国、32429
- Johannes Wesling Klinikum Minden
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接触:
- Ralf Gutzmer, MD
- 电话号码:+49 (0)571 7904501
- 邮箱:dermatologie-minden@muehlenkreiskliniken.de
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首席研究员:
- Ralf Gutzmer, MD
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Rostock、德国、18057
- University Medical Center Rostock
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接触:
- Markus Thieme, MD
- 电话号码:+49 (0) 381 494 9789
- 邮箱:Markus.Thieme@med.uni-rostock.de
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首席研究员:
- Markus Thieme, MD
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Tübingen、德国、72076
- University Medical Center Tübingen
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首席研究员:
- Ulrike Leiter, MD
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接触:
- Ulrike Leiter, MD
- 电话号码:+49 (0)7071 2984555
- 邮箱:ulrike.leiter@med.uni-tuebingen.de
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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.
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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.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
大体时间:From start of cemiplimab treatment through 6 months
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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.
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From start of cemiplimab treatment through 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective Response Rate
大体时间:From start of cemiplimab treatment through 24 months
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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.
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From start of cemiplimab treatment through 24 months
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Progression-Free Survival
大体时间:From start of cemiplimab treatment through 24 months
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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.
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From start of cemiplimab treatment through 24 months
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Overall Survival
大体时间:From start of cemiplimab treatment through 24 months
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Overall survival is defined as the time from initiation of cemiplimab treatment to death from any cause.
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From start of cemiplimab treatment through 24 months
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Thromboembolic Events During Follow-up
大体时间:From start of cemiplimab treatment through 24 months
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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
大体时间:From start of cemiplimab treatment through 6 months
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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.
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From start of cemiplimab treatment through 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Glenn Geidel, MD, MSc、Universitätsklinikum Hamburg-Eppendorf
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- D-TECT
- DRKS00040746 (注册表标识符:German Clinical Trials Register)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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