EUCTR2019-001469-34-IT进行中（未招募）1 期
A phase II, single arm study investigating neoadjuvant plus adjuvant treatment with Cemiplimab in high risk, surgically resectable, stage III Cutaneaous Squamous Cell Carcinoma - NEO-CESQ
FONDAZIONE MELANOMA ONLUS0 个研究点目标入组 25 人开始时间: 2020年10月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Patients of either sex aged =18 years.
- •2)Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •3)Patients must have histologically or cytologically locally advanced cutaneous squamous cell carcinomas. 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.
- •4)Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team.
- •5)Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- •6)Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •7)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.
- •8)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 16 weeks (i.e., 30 days plus the time required for cemiplimab to undergo five half-lives) after the last dose of cemiplimab.
- •9)Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 16 weeks (i.e., 80 days plus the time required for cemiplimabto undergo five half-lives) after the last dose of cemiplimab.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1)Evidence of metastatic disease extra lymphnodal.
- •2)Currently and previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug.
- •3)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.
- •4)Any major surgery within the last 3 weeks.
- •5)Unwillingness or inability to follow the procedures required in the protocol.
- •6)Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity.
- •7)Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment.
- •8)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.
- •9)Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
- •10)Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
研究者
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