Locally advanced or metastatic cutaneous squamous cell carcinoma
Conditions
Interventions
Group 1: Patients with locally advanced or metastatic cutaneous squamous cell carcinoma treated with cemiplimab in routine clinical care and a pretreatment D-dimer level >0.91 mg/L FEU.
Group 2: Patie
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 • ECOG performance status 0 to 2 • Written informed consent for study participation and pseudonymized collection and analysis of clinical and laboratory data
Exclusion criteria
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
Design outcomes
Primary
| Measure | 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 (CR), partial response (PR), or stable disease (SD) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include objective response rate (ORR), defined as the proportion of participants with complete or partial response according to clinical and/or radiological assessment in routine care, progression-free survival (PFS), defined as the time from initiation of cemiplimab treatment to the first documented disease progression or death from any cause, and overall survival (OS), defined as the time from initiation of cemiplimab treatment to death from any cause. In addition, venous and arterial thromboembolic events occurring during follow-up will be documented and evaluated in relation to pretreatment D-dimer levels. Diagnostic performance measures 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 six months will also be assessed, including sensitivity, specificity, positive predictive value, and negative predictive value. Further prespecified exploratory analyses include cumulative incidence of documented disease progression accounting for death without prior documented progression as a competing event, multivariable models evaluating the association between pretreatment D-dimer levels and clinical outcomes while accounting for clinical covariates, and exploratory analyses of assay- and reference-range-related heterogeneity in D-dimer measurements across participating centers. | — |
Countries
Austria, Germany
Contacts
Public ContactGlenn Geidel
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed