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

NCT07064330 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

DRUG

Cemiplimab

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

Sponsors & Collaborators

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • University of Salamanca

    collaborator OTHER

  • Instituto de Investigación Biomédica de Salamanca

    lead OTHER

Principal Investigators

  • Javier Cañueto, Medical Degree in Dermatology · Centro Asistencial Universitario de Salamanca (CAUSA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064330 on ClinicalTrials.gov