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

Sponsor
Instituto de Investigación Biomédica de Salamanca
Study ID
NCT07064330
Status
Recruiting
Apply to this trial

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 17, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Observational Cohort
    All enrolled patients will receive cemiplimab as part of standard clinical care for advanced cutaneous squamous cell carcinoma (CSCC). Cemiplimab is not assigned by the study but is administered as per physician's decision in routine practice.

Primary Outcome Measure

Biomarker signature associated with cemiplimab response [ Time Frame: Up to 6 months from treatment initiation ]

Central Contacts

Related Studies