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Mechanisms of Resistance to anti-PD-1 Therapy in cutaneous Squamous Cell Carcinomas: Impact of Tumor Cell Plasticity on Promoting Myeloid Suppressor Cell Infiltration. A phase II single arm, unicenter study of cemiplimab in patients with locally advanced cSCCs.
EU CTIS ID: 2025-524255-32-00
What this study is testing
To characterize the immune environment and tumor cell plasticity in patients with cutaneous squamous cell carcinoma (cSCC) treated with cemiplimab, in order to identify mechanisms of resistance to anti-PD-1 therapy and potential biomarkers or new therapeutic targets.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female subjects ≥ 18 years old.
- 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.
- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- 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).
- No prior systemic treatment for the cSCC.
- Patients must have enough tumor size to allow performing all biological tests detailed in Section 5.1.
You likely can't join if
- Untreated known brain metastasis(es) that may be considered active.
- Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
- History of pneumonitis within the last 5 years.
- Receipt of a live vaccine within 4 weeks of start of study medication
- 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.
- Known hypersensitivity to the active substances or to any of the excipients.
See the full eligibility criteria
Who can join
- Male or female subjects ≥ 18 years old.
- 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.
- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- 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).
- No prior systemic treatment for the cSCC.
- Patients must have enough tumor size to allow performing all biological tests detailed in Section 5.1.
- Eastern Cooperative Oncology Group performance-status (ECOG PS) score of 0 or 1.
- Adequate organ and bone marrow function according parameters hepatic function, renal function, Creatine phosphokinase (CPK) and Bone marrow function.
- Anticipated life expectancy >12 weeks.
- 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.
What rules you out
- Untreated known brain metastasis(es) that may be considered active.
- Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
- History of pneumonitis within the last 5 years.
- Receipt of a live vaccine within 4 weeks of start of study medication
- 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.
- Known hypersensitivity to the active substances or to any of the excipients.
- 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)
- Positive serum pregnancy test or pregnant females.
- Breastfeeding females.
- Patients who have a known secondary malignancy that is progressing or has required active treatment within the past 2 years.
- 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.
- 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.
- Presence of cardiovascular disease, as defined by: a. New 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. Transient ischemic attack or stroke within 1 year
- 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).
- Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients must be excluded.
- History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
- 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.
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.