Actively Recruiting

Age: 18Years +
All Genders
NCT07064330

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

Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2025-09-10

30

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigación Biomédica de Salamanca

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Total bilirubin �3x upper limit of normal (ULN) if Gilbert's Disease, otherwise �1.5x ULN (or �3x ULN if liver metastases)
  • Transaminases �4x ULN (or �5x ULN if liver metastases)
  • Alkaline phosphatase �2.5x ULN (or �5x ULN if liver or bone metastases)
  • Serum creatinine �2x ULN or estimated creatinine clearance over 35 mL/min
  • Creatine phosphokinase elevation grade 2 or less
  • Hemoglobin �9.0 g/dL or higher
  • Absolute neutrophil count �1.5 x 10^9/L or higher
  • Platelet count �75 x 10^9/L or higher
  • Anticipated life expectancy longer than 12 weeks
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Unsuitable for cemiplimab treatment
  • Ongoing or recent (within 5 years) significant autoimmune disease requiring systemic immunosuppressive treatment (except controlled vitiligo, resolved childhood asthma, type 1 diabetes, stable hypothyroidism, or psoriasis not needing systemic treatment)
  • Untreated or active brain metastases
  • Use of immunosuppressive corticosteroids over 10 mg prednisone daily within 4 weeks before starting cemiplimab
  • Active infections requiring treatment, including HIV, hepatitis B, or hepatitis C
  • History of pneumonitis within the last 5 years
  • Any anticancer treatment other than radiation therapy within 30 days before cemiplimab or planned during study
  • History of allergic reactions to antibody treatments or cemiplimab
  • History of solid organ transplant (except prior corneal transplant with approval)
  • Breastfeeding
  • Positive serum pregnancy test
  • Receipt of live vaccines within 30 days before first treatment
  • Women of childbearing potential or sexually active men not willing to use effective contraception during and for 6 months after treatment
  • Prior PD-1/PD-L1 inhibitor treatment with severe immune-related adverse events
  • Prior systemic immune-modulating agents within 28 days before treatment (topical or intralesional agents like imiquimod are allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Complejo Asistencial Universitario de Salamanca

Salamanca, Salamanca, Spain, 37007

Actively Recruiting

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Research Team

R

Ricardo López, Study Project Manager

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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