Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.
Trial Parameters
Brief 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 Criteria
\- Inclusion criteria At least 18 years old Hepatic function: 1. Total bilirubin ≤1.5x upper limit of normal (ULN) (or ≤3x ULN, if liver metastases). 2. Patients with Gilbert's Disease and total bilirubin up to 3x ULN may be eligible after communication with and approval from the medical monitor 3. Transaminases ≤3x ULN (or ≤5x ULN, if liver metastases) 4. Alkaline phosphatase (ALP) ≤2.5x ULN (or ≤5x ULN, if liver or bone metastases) Renal function: Serum creatinine ≤2x ULN or estimated creatinine clearance \>35 mL/min (according the method of Cockcroft and Gault) Creatine phosphokinase (CPK) (also known as CK \[creatine kinase\]) elevation ≤ grade 2 Bone marrow function: a. Hemoglobin ≥9.0 g/dL b. Absolute neutrophil count (ANC) ≥1.5 x 109/L c. Platelet count ≥75 x 109/L Anticipated life expectancy \>12 weeks \- Exclusion criteria: 1. \- Patient who refuses to participate in the study. 2. Being unsuitable for cemiplimab treatment 3. Ongoing or recent (within 5 years) evidence of signi