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Blood clot marker may predict immunotherapy success in advanced skin cancer

NCT ID NCT07684066

Knowledge-focused Sponsor: Universitätsklinikum Hamburg-Eppendorf Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study looks at whether a routine blood test measuring D-dimer levels can predict if the immunotherapy drug cemiplimab will control advanced cutaneous squamous cell carcinoma. Researchers will follow 116 patients starting cemiplimab in regular care, comparing disease control rates between those with high versus low D-dimer levels. No extra treatments or tests are required beyond standard care. If validated, this simple marker could help personalize treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If D-dimer levels reliably predict treatment response, doctors could tailor cemiplimab therapy for advanced skin cancer patients, avoiding ineffective treatment.
What could go wrong
This is an observational study, not a treatment trial. The D-dimer test may not prove useful in real-world settings, and results may not change patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic squamous cell carcinoma skin squamous cell carcinoma thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cutaneous squamous cell carcinoma Cutaneous squamous cell carcinoma (CSCC) Metastatic cutaneous squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Elbe Klinikum Buxtehude

    Buxtehude, 21614, Germany

  • Hannover Medical School

    Hanover, 30625, Germany

  • Johannes Wesling Klinikum Minden

    Minden, 32429, Germany

  • Klinikum Bremerhaven Reinkenheide

    Bremerhaven, 27574, Germany

  • University Medical Center Erlangen

    Erlangen, 91054, Germany

  • University Medical Center Göttingen

    Göttingen, 37075, Germany

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • University Medical Center Mainz

    Mainz, 55131, Germany

  • University Medical Center Mannheim

    Mannheim, 68167, Germany

  • University Medical Center OWL, Campus Klinikum Bielefeld Rosenhöhe

    Bielefeld, 33647, Germany

  • University Medical Center Rostock

    Rostock, 18057, Germany

  • University Medical Center Salzburg

    Salzburg, 5020, Austria

  • University Medical Center Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • University Medical Center Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538, Germany

  • University Medical Center Tübingen

    Tübingen, 72076, Germany

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