EUCTR2019-004052-11-FR进行中（未招募）1 期
A phase II trial assessing Bintrafusp alfa, a bifunctional fusion protein targeting TGF-ß and PD-L1, in a pre-operative setting for resectable and untreated head and neck squamous cell carcinoma - ICING
ICANCER0 个研究点目标入组 59 人开始时间: 2020年3月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
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.Age =18 years
- •2.Patients must have signed a written informed consent form prior to any trial specific procedures
- •3.Histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of HNSCC of occult primary could not be enrolled.
- •In order to avoid repeated biopsies procedures under general anesthesia, patients with clinically highly suspected squamous cell carcinoma could be registered before the histological or cytological proof. In these cases, the diagnosis will be confirmed rapidly after the endoscopy, either by using frozen sections or by reporting the results obtained on FFPE within no more than 5 working days.
- •4.Absence of distant metastases determined by CT scan or Pet CT that must be performed within 35 days prior to endoscopy.
- •5.According to the 7th edition AJCC eligible stages are as follow:
- •T2N1, T2N2, T2N3
- •T3 or T4 (any N)
- •6.Baseline radiology studies evaluating primary tumor (MRI or CT scan) must be performed within 28 days prior to endoscopy.
- •7.Patients must have at least 1 lesion superior to 2 cm in larger axis
- •8.ECOG performance status =1
- •9.Adequate organ and marrow function as defined by the following laboratory results obtained within 28 days prior to the baseline endoscopy:
- •a)Hemoglobin (Hb) =9,0 g/dL;
- •b)Absolute neutrophil count (ANC) =1,500/mm3;
- •c)Platelet count =100,000/mm3;
- •d)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =1.5 × institutional upper limit of normal (ULN);
- •e)Total bilirubin =1.5 × ULN;
- •f)Creatinine clearance >30 mL/min as determined by the Cockcroft-Gault equation (Cockcroft and Gault, 1976)
- •10.Negative serology for hepatitis B and C
- •11.Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- •12.Willing and able to provide tumor specimen and blood samples for translational research.
- •13.Women of childbearing potential must have a negative serum ß-HCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment.
- •14.Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 2 months after last dose of study drugs.
- •15.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •16.Patients must be affiliated to the social security system or equivalent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1.Primary site of head and neck carcinoma in nasopharynx, sinuses, or skin
- •2.Patients receiving other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) or other investigational agent within 6 months prior to the first dose of study drug and while on study treatment.
- •3.Patients receiving other anti-cancer non-drug therapies: radiation, or tumor embolization within 6 months prior to the first dose of study drug and while on study treatment.
- •4.Previous or concurrent cancer within 2 years prior to study inclusion, with the exception of the following cancer types: in situ carcinomas of any location; skin basal cell carcinoma or squamous cell carcinoma stage T1N0M0 or T2N0M0
- •5.Any previous treatment with a PD-1, PD-L1 agent
- •6.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses.
- •7.Current or prior use of immunosuppressive medication within 28 days before the first dose of bintrafusp alfa, with the exceptions of intranasal, intraocular and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
- •8.Receipt of live attenuated vaccination within 30 days prior to the first administration of bintrafusp alfa
- •9.Active or prior documented autoimmune disease within the past 2 years.
- •NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) can be enrolled
- •10.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
- •11.History of primary immunodeficiency
- •12.History of allogenic organ transplant that requires the use of immunosuppressive drugs
- •13.Pregnant or breast-feeding women
- •14.Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- •15.Known positive HIV status
- •16.Participation in another clinical study with an investigational product during the last 30 days.
- •17.Known hypersensitivity to the study drug, study drug classes, or study drug excipients.
- •18.Patients under guardianship or deprived of his liberty by a judicial or administrative decision or any condition (e.g., psychiatric illness/social/familial/geographical condition) that would limit compliance with study requirement or compromise the ability of the patients to give written informed consent
研究者
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