EUCTR2016-004632-38-SK进行中（未招募）1 期
Phase II study of Avelumab in multiple relapsed/refractory testicular germ cell cancer. - GCTSK005
árodný onkologický ústav0 个研究点目标入组 43 人开始时间: 2017年8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
- 43
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
- Male
入选标准
- •1)Signed written informed consent
- •2)Men aged 18 years or older
- •3)ECOG performance status: 0-1
- •4)Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
- •5)Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
- •6)Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy
- •7)Primary mediastinal GCTs in first relapse
- •8)Patient’s disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator,
- •9)RECIST 1.1 Measurable disease
- •10)Adequate hematologic function defined by ANC = 1500/mm3, platelet count = 100 000/mm3 and hemoglobin level = 9g/dl.
- •11)Adequate liver function defined by a total bilirubin level = 1.5 ULN, and ALT, AST = 2.5 × ULN . or AST and ALT levels = 5 x ULN (for subjects with documented metastatic disease to the liver).
- •12)Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance = 30 ml/min. Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)]
- •13)At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry,
- •14)At least 4 weeks must have elapsed since the last major surgery
- •15)Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1,
- •16)Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •17)Highly effective contraception for both male and female subjects if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 30 days after avelumab treatment.
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 43
排除标准
- •1)Patients who do not fit inclusion criteria
- •2)Other prior malignancy except successfully treated non-melanoma skin cancer
- •3)No prior PD-1/PD-L1 inhibitor
- •4)Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
- •5)Female patients
- •6)Patients infected by the Human Immunodeficiency Virus (HIV)
- •7)Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- •8)Other significant diseases: e.g. immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior;
- •Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with the study participation, study treatment administration, or may interfere with the interpretation of study results and, which, in judgment of the investigator, would make the patient inappropriate for entry into this study
- •9)Hypersensitivity to any compound of the drug
- •10)Sexually active men not using highly effective birth control if their partners are women of child-bearing potential
- •11)All subjects with brain metastases, except those meeting the following criteria:
- •- Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
- •- No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
- •- Subjects must be either off steroids or on a stable or decreasing dose of <10mg daily prednisone (or equivalent)
- •12)Prior organ transplantation, including allogeneic stem cell transplantation
- •13)Significant acute or chronic infections including, among others:
- •14)Active infection requiring systemic therapy
- •-Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •- Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive)
- •15)Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
- •a. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •b. Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses = 10 mg or 10 mg equivalent prednisone per day
- •c. Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation...) are acceptable
- •d. steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
- •16)Known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- •17)Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v
研究者
相似试验
招募中
不适用
A phase II study of avelumab in relapsed or refractory stage III/IV extranodal natural killer/T-cell lymphomaNeoplasmsKCT0003206Samsung Medical Center33
尚未招募
不适用
Phase 1B/Phase 3 Multicenter Study of Avelumab (MSB0010718c) in Combination Regimens that Include an Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)NL-OMON47269Pfizer4
已完成
2 期
Avelumab in Refractory Testicular Germ Cell Cancer.Testicular NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasmsTesticular DiseasesGonadal DisordersAntineoplastic AgentsMolecular Mechanisms of Pharmacological ActionNCT03403777National Cancer Institute, Slovakia8
进行中（未招募）
1 期
Avelumab in combination with Axitinib in patients with advanced Thymic tumoursHistologically confirmed advanced Thymoma B3 or Thymic carcinoma inoperable (Masaoka Stage IIIb or IV).MedDRA version: 21.1Level: PTClassification code 10055108Term: Thymic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004048-38-ITISTITUTO EUROPEO DI ONCOLOGIA33
招募中
2 期
A Phase II, single arm Study of avelumab in combination with Axitinib in Patients with unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapy - AXAGIST2024-519176-95-00Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy58