EUCTR2019-004628-39-GB进行中（未招募）1 期
A phase II study of neoadjuvant immune checkpoint inhibitors in urothelial cancer - ABACUS-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
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.Willing and able to provide written informed consent
- •2.Ability to comply with the protocol
- •3.Age = 18 years
- •4.Residual disease after TURBT or URS (surgical opinion, endoscopy or radiological presence).
- •5.Fit and planned for radical surgery with curative intent in the opinion of the investigator (according to local guidelines).
- •6.N0 or M0 disease CT or MRI (within 4 weeks of registration)
- •7.Representative formalin-fixed paraffin embedded (FFPE) tumour samples with an associated pathology report that are determined to be available and sufficient for central testing.
- •8.Patients who refuse neoadjuvant cisplatin-based chemotherapy or in whom neoadjuvant cisplatin- based therapy is not appropriate.
- •9.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •10.Negative pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential.
- •11.For female patients of childbearing potential to use a highly effecting form(s) of contraception (i.e. one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of atezolizumab.
- •12.Adequate hematologic and end-organ function within 4 weeks prior to the first study treatment defined by the following:
- •a)ANC = 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- •b)WBC counts > 2500/µL
- •c)Lymphocyte count = 500/µL
- •d)Platelet count = 100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- •e)Haemoglobin = 9.0 g/dL (patients may be transfused or receive erythropoietic treatment to meet this criterion).
- •f)AST or ALT, and alkaline phosphatase = 2.5 times the institutional upper limit of normal (ULN) (patients with known Gilbert disease who have serum bilirubin level = 3 × the institutional ULN may be enrolled).
- •g)INR and aPTT = 1.5 × the institutional ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- •h)Calculated creatinine clearance = 20 mL/min (Cockcroft-Gault formula)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1.Pregnant and lactating female patients.
- •2.Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
- •3.Previously intravenous chemotherapy for urothelial cancer.
- •4.Patients with prior allogeneic stem cell or solid organ transplantation.
- •5.Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- •6.Patients must not have had oral or IV steroids for 14 days prior to study entry. The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone) is allowed.
- •7.Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrolment (Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible).
- •8.Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.
- •9.Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment.
- •10.Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment.
- •11.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease.
- •12.Malignancies other than UC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer.
- •13.Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- •14.Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias, or unstable angina.
- •15.History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan.
- •16.Patients with uncontrolled Type 1 diabetes mellitus. Patients with Type 1 diabetes controlled on a stable insulin regimen are eligible.
- •17.Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •18.Positive test for HIV
- •19.Patients with active tuberculosis
- •20. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the
- •absorption of the study drug.
- •21. Uncontrolled hypercalcemi
研究者
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