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D-TECT: Pretreatment D-dimers and Disease Control in Advanced cSCC Treated With Cemiplimab (D-TECT)

2026年7月21日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

116

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Glenn Geidel, MD, MSc
  • 電話番号:+49 (0)40 7410 70743
  • メール:g.geidel@uke.de

研究場所

      • Salzburg、オーストリア、5020
        • University Medical Center Salzburg
        • コンタクト:
          • Matthias Brandlmaier, MD, PhD, MSc
          • 電話番号:+43 (0) 57255 24601
          • メール:m.brandlmaier@salk.at
        • 主任研究者:
          • Matthias Brandlmaier, MD, PhD, MSc
      • Bielefeld、ドイツ、33647
        • University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe
        • コンタクト:
        • 主任研究者:
          • Selma Ugurel, MD
      • Bremerhaven、ドイツ、27574
        • Klinikum Bremerhaven Reinkenheide
        • コンタクト:
        • 主任研究者:
          • Michael M. Sachse, MD
      • Buxtehude、ドイツ、21614
        • Elbe Klinikum Buxtehude
        • コンタクト:
        • 主任研究者:
          • Kai-Martin Thoms, MD
      • Erlangen、ドイツ、91054
        • University Medical Center Erlangen
        • コンタクト:
        • 主任研究者:
          • Markus V. Heppt, MD, PhD, MHBA
      • Göttingen、ドイツ、37075
        • University Medical Center Göttingen
        • コンタクト:
        • 主任研究者:
          • Katharina Amschler, MD
      • Hamburg、ドイツ、20246
        • University Medical Center Hamburg-Eppendorf
        • コンタクト:
          • Glenn Geidel, MD, MSc
          • 電話番号:+49 (0)40 741070743
          • メール:g.geidel@uke.de
        • 主任研究者:
          • Glenn Geidel, MD, MSc
      • Hanover、ドイツ、30625
        • Hannover Medical School
        • コンタクト:
        • 主任研究者:
          • Imke von Wasielewski, MD
      • Kiel、ドイツ、24105
        • University Medical Center Schleswig-Holstein, Campus Kiel
        • 主任研究者:
          • Katharina Kähler, MD
        • コンタクト:
      • Lübeck、ドイツ、23538
        • University Medical Center Schleswig-Holstein, Campus Lübeck
        • コンタクト:
        • 主任研究者:
          • Dagmar von Bubnoff, MD
      • Mainz、ドイツ、55131
        • University Medical Center Mainz
        • コンタクト:
        • 主任研究者:
          • Henner Stege, MD
      • Mannheim、ドイツ、68167
        • University Medical Center Mannheim
        • 主任研究者:
          • Jochen Utikal, MD
        • コンタクト:
      • Minden、ドイツ、32429
      • Rostock、ドイツ、18057
        • University Medical Center Rostock
        • コンタクト:
        • 主任研究者:
          • Markus Thieme, MD
      • Tübingen、ドイツ、72076
        • University Medical Center Tübingen
        • 主任研究者:
          • Ulrike Leiter, MD
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease Control Rate Within the First 6 Months of Cemiplimab Treatment
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate
時間枠: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
Progression-Free Survival
時間枠: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
Overall Survival
時間枠: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
時間枠: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.
From start of cemiplimab treatment through 24 months
Diagnostic Performance of Prespecified D-dimer Cutoffs for 6-Month Disease Control
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Cumulative Incidence of Documented Disease Progression Accounting for Death as a Competing Event
時間枠:From start of cemiplimab treatment through 24 months
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
時間枠:From start of cemiplimab treatment through 24 months
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
時間枠:Baseline through 24 months
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Glenn Geidel, MD, MSc、Universitätsklinikum Hamburg-Eppendorf

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2028年7月31日

研究の完了 (推定)

2030年3月31日

試験登録日

最初に提出

2026年6月28日

QC基準を満たした最初の提出物

2026年6月28日

最初の投稿 (実際)

2026年7月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月22日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • D-TECT
  • DRKS00040746 (レジストリ識別子:German Clinical Trials Register)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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