CEMIPLIMAB for Cutaneous squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Male or female subjects ≥ 18 years old."}
• {"criterion_text":"- For both male and female patients/partners: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for 4 months after the last dose of study treatment."}
• {"criterion_text":"- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities."}
• {"criterion_text":"- Locally advanced cSCC (T2-4, N0, M0). Including both resectable and unresectable disease, with no selection based on resectability status, provided that patients meet Criterion 5 (adequate tumor tissue available for all planned biological analyses)."}
• {"criterion_text":"- No prior systemic treatment for the cSCC."}
• {"criterion_text":"- Patients must have enough tumor size to allow performing all biological tests detailed in Section 5.1."}
• {"criterion_text":"- Eastern Cooperative Oncology Group performance-status (ECOG PS) score of 0 or 1."}
• {"criterion_text":"- Adequate organ and bone marrow function according parameters hepatic function, renal function, Creatine phosphokinase (CPK) and Bone marrow function."}
• {"criterion_text":"- Anticipated life expectancy >12 weeks."}
• {"criterion_text":"- Female subjects of childbearing potential (WOCBP) must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method for the duration of the study treatment and for 6 months after the last dose of study treatment."}

Exclusion criteria

• {"criterion_text":"- Untreated known brain metastasis(es) that may be considered active."}
• {"criterion_text":"- Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent)."}
• {"criterion_text":"- History of pneumonitis within the last 5 years."}
• {"criterion_text":"- Receipt of a live vaccine within 4 weeks of start of study medication"}
• {"criterion_text":"- Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication."}
• {"criterion_text":"- Known hypersensitivity to the active substances or to any of the excipients."}
• {"criterion_text":"- Women of childbearing potential (WOCBP)*, or sexually active men**, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 6 months after the last dose (refer to Appendix 3)"}
• {"criterion_text":"- Positive serum pregnancy test or pregnant females."}
• {"criterion_text":"- Breastfeeding females."}
• {"criterion_text":"- Patients who have a known secondary malignancy that is progressing or has required active treatment within the past 2 years."}
• {"criterion_text":"- Any underlying medical or psychiatric disorder, which, in the opinion of the investigator, makes the administration of cemiplimab unsafe or interferes with the informed consent process or trial procedures."}
• {"criterion_text":"- Any anticancer treatment other than radiation therapy (chemotherapy, targeted systemic therapy, imiquimod, photodynamic therapy), investigational or standard of care, within 30 days of the initial administration of cemiplimab or planned to occur during the study period."}
• {"criterion_text":"- Presence of cardiovascular disease, as defined by: a.\tNew York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b.\tTransient ischemic attack or stroke within 1 year"}
• {"criterion_text":"- Patients with a history of solid organ transplants (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the principal investigator)."}
• {"criterion_text":"- Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients must be excluded."}
• {"criterion_text":"- History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments"}
• {"criterion_text":"- Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded."}
• {"criterion_text":"- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments."}
• {"criterion_text":"- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication"}

Primary endpoints

• {"endpoint_text":"- Primary translational end points are immunologic, genomic, and pathological correlations of response to cemiplimab in blood and tumor samples.","definition_or_measurement_approach":"Correlations of immunologic, genomic and pathological measures in blood and tumor samples to response to cemiplimab (translational analyses on collected blood and tumor specimens)."}

Secondary endpoints

• {"endpoint_text":"- Flow cytometry assays","definition_or_measurement_approach":"Flow cytometry analysis of immune cell populations in blood/tumor samples."}
• {"endpoint_text":"- Multiplex immunohistochemistry","definition_or_measurement_approach":"Multiplex immunohistochemistry assays on tumor tissue to characterize cell populations and markers."}
• {"endpoint_text":"- Single-cell RNA (scRNA) Seq assays","definition_or_measurement_approach":"Single-cell RNA sequencing of tumor/immune cells to profile heterogeneity."}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":"Time from treatment start to disease progression or death (PFS), as per study analyses (definition not further specified in provided record)."}
• {"endpoint_text":"- Overall Response Rate (ORR) per RECIST 1.1","definition_or_measurement_approach":"Tumor response assessed using RECIST 1.1 criteria to derive ORR."}

Spain

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

32

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain