EUCTR2020-005703-39-FR招募中1 期
Bintrafusp alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. - TRUST
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas).
- •2.Metastatic or unresectable locally advanced disease,
- •3.No previous systemic treatment for advanced/metastatic disease,
- •4.For TLS status: available archived FFPE tumor tissue sample or tumor material newly obtained by biopsy.
- •5.Age = 18 years,
- •6.ECOG = 1,
- •7.Life expectancy > 3 months,
- •8.Patients must have measurable disease defined as per RECIST v1.1,
- •9.Patient must comply with the collection of tumor biopsies and biomarkers study. Tumors must be accessible for biopsy,
- •10.Adequate hematological, renal, metabolic and hepatic function:
- •a)Hemoglobin = 9 g/dl (patients may not have received prior red blood cell transfusion in the last 30 days); absolute neutrophil count = 1.5 G/l, and platelet count = 100 G/l.
- •b)Alanine aminotransferase, aspartate aminotransferase = 1.5 x ULN (= 5 in case of extensive liver involvement) and alkaline phosphatase = 2.5 x ULN
- •c)Total bilirubin = ULN (= 3 in case of liver involvement)
- •d)Albumin = 30 g/l
- •e)Creatinine level = 1.5 x ULN or calculated creatinine clearance = 40 ml/min (according to Cockroft Gault formula)
- •f)INR, PT = 1.5 x ULN and aPTT = 1.5 x ULN.
- •11.Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
- •12.Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least two months after discontinuation of treatment for women and four months for men.
- •13.No prior or concurrent malignant disease diagnosed or treated in the last 3 years except for a. Superficial/non-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in > 1 year,
- •14.Recovery to grade = 1 from any adverse event derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade = 2) according to the NCI-CTCAE, version 5.0,
- •15.Voluntarily signed and dated written informed consent prior to any study specific procedure,
- •16.Patients with a social security in compliance with the French law.
- •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 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1.Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin and/or any other anthracyclines or anthracediones at the maximum cumulative dose or any approved or investigational treatment targeting PD1, PD-L1 or TGFB1,
- •2.Known central nervous system malignancy,
- •3.Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
- •4.Participation to a study involving a medical or therapeutic intervention in the last 30 days,
- •5.Previous enrolment in the present study,
- •6.Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
- •7.Known hypersensitivity to any involved study drug or any of its formulation components,
- •8. Any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma,
- •9.Individuals deprived of liberty or placed under legal guardianship,
- •10.Any of the following cardiac criteria:
- •a)Mean QTcF = 470 msec, obtained from three consecutive ECGs,
- •b)Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG,
- •c)LVEF = 50% per CTCAE v5
- •d)Any factors increasing the risk of QTc prolongation or arrhythmic events ,
- •e)Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, uncontrolled hypertension, congestive heart failure NYHA Grade =2, ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks, cerebral vascular accident/stroke or any other central nervous system bleeding
- •11.Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •12.History of bleeding diathesis or recent major bleeding event (i.e. Grade = 2 bleeding events within 30 days prior to treatment,
- •13.Prior organ transplantation including allogenic stem-cell transplantation, except transplants that do not require immunosuppression,
- •14.Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, drug-induced interstitial lung disease (ILD) or subject has had a history of drug-induced pneumonitis that has required oral or IV steroids, and/or other diseases, which in the opinion of the investigator might impair the subject’s tolerance for the study or ability to consistently participate in study procedures,
- •15.Active infection including tuberculosis,
- •16.Has known active hepatitis B or hepatitis C,
- •17.Has a known history of HIV infection,
- •18.Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. ,
- •19.Patients with current or history of deep vein thrombosis within 6 months prior to randomization,
- •20.Any contraindication to biopsy for the research,
- •21.Any other contraindication to Doxorubicin administration,
- •22.Patients with oral anticoagulation therapy based on Vitamin K antagonist.
- •23.Prior mediastinal radiation.
研究者
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