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Study of Cemiplimab in Patients with type of skin cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
EU CTIS ID: 2022-500811-37-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by pCR rate per independent central pathology review.
- 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
- Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
- At least 1 lesion that is measurable by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ, bone marrow function, and hepatic function as defined in the protocol NOTE: Other protocol defined Inclusion Criteria apply
You likely can't join if
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
- Distant metastatic disease (M1), visceral and/or distant nodal
- Prior radiation therapy for CSCC
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management
See the full eligibility criteria
- Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
- At least 1 lesion that is measurable by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ, bone marrow function, and hepatic function as defined in the protocol NOTE: Other protocol defined Inclusion Criteria apply
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
- Distant metastatic disease (M1), visceral and/or distant nodal
- Prior radiation therapy for CSCC
- Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
- Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
- Active tuberculosis NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply
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, 18-64 years, 65+ 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.