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“A phase II, single arm study investigating neoadjuvant plus adjuvant treatment with Cemiplimab in surgically resectable, high risk stage III/IV (M0) Cutaneaous Squamous Cell Carcinoma”
EU CTIS ID: 2024-515204-39-00
What this study is testing
neoadjuvant plus adjuvant treatment with immunotherapy may have an anti-tumor activity and reduce the risk of relapse in patients with surgically resectable, high risk stage III/IV (M0)squamous cell carcinoma.
- 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
- Patients of either sex aged ≥18 years.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Patients must have histologically or cytologically surgically resectable, high risk stage III/IV (M0) cutaneous squamous cell carcinoma. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumor Conference attended by CSCC medical and surgical oncology staff. Resectable tumors are defined as having no significant vascular, neural or bony involvement.
- Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team.
- Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
You likely can't join if
- Evidence of metastatic disease extra limphnodal
- Currently or previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
- Prior malignancy within the prior 5 years, except for the following: in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years
- Any major surgery within the last 3 weeks
- Unwillingness or inability to follow the procedures required in the protocol
- Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity
See the full eligibility criteria
Who can join
- Patients of either sex aged ≥18 years.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Patients must have histologically or cytologically surgically resectable, high risk stage III/IV (M0) cutaneous squamous cell carcinoma. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumor Conference attended by CSCC medical and surgical oncology staff. Resectable tumors are defined as having no significant vascular, neural or bony involvement.
- Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team.
- Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients must have organ and marrow function as defined below: absolute neutrophil count (ANC) ≥1.5 X 10^9/L; hemoglobin ≥9-5 g/dL; platelets ≥100 X 10^9/L; prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤1.5 X upper limit of normal (ULN); total bilirubin ≤1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN ^1; albumin ≥2.5 g/dL; creatinine ≤1.5 X ULN 2 OR calculated creatinine clearance ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min
- Female subjects of childbearing potential must have a negative pregnancy test result at baseline and must practice a reliable method of contraception for the total study duration plus 6 months after the last dose of cemiplimab
- Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 6 months after the last dose of cemiplimab
What rules you out
- Evidence of metastatic disease extra limphnodal
- Currently or previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
- Prior malignancy within the prior 5 years, except for the following: in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years
- Any major surgery within the last 3 weeks
- Unwillingness or inability to follow the procedures required in the protocol
- Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
- Female subjects who are pregnant (positive pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
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.
Explore other conditions
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.