RecruitingNCT07064330

Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.

Next Generation Flow Cytometry for Global Immunological Profile, Response And Toxicity Biomarker Signatures in Cutaneous Squamous Cell Carcinoma Under CEmiplimab Treatment.


Sponsor

Instituto de Investigación Biomédica de Salamanca

Enrollment

30 participants

Start Date

Jul 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Cutaneous squamous cell carcinoma (CSCC) is the second most frequent cancer in humans, it exhibits a high tumor mutational burden and is more common in immunocompromised patients, which aimed to explore the impact of immunotherapy in this cancer. CSCC shows good response to anti-PD1 immunotherapy, and cemiplimab is the first FDA-approved and the only EMA-approved treatment for this tumor. However, 50% of patients won't respond to anti-PD1 and to date there is little evidence on the reasons for such a lack of effectiveness. Also, anti-PD1 immunotherapy is very safe, but some patients will develop adverse events, and anticipating severe adverse events might help in patients' management. The NGF-GRACE project aims to find biomarkers of response and toxicity, both in the blood and the tumor, using advanced technologies. The goal is to move towards more personalized treatments, better select patients, predict side effects, and improve our understanding of the immune system in CSCC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses advanced immune cell profiling (next-generation flow cytometry) to monitor the immune system response in skin cancer patients receiving cemiplimab (an immunotherapy drug), aiming to find markers that predict who will respond to treatment or develop side effects. **You may be eligible if...** - You are 18 years or older - You have a skin cancer diagnosis being treated with cemiplimab - Your liver, kidney, and blood cell function are within acceptable limits (specific lab value thresholds apply) **You may NOT be eligible if...** - Your liver, kidney, or bone marrow function is significantly impaired - You have a condition that makes immunotherapy unsafe - You do not meet the lab value thresholds required for study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

350 mg IV every 3 weeks as per standard of care. Patients are observed prospectively for biomarkers of response and toxicity during cemiplimab treatment.


Locations(1)

Complejo Asistencial Universitario de Salamanca

Salamanca, Salamanca, Spain

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NCT07064330


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