ISRCTN83474167进行中（未招募）2 期
Atezolizumab in patients with urinary tract squamous cell carcinoma: a single arm, open label, multicentre, phase II clinical trial
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 36 人开始时间: 2022年11月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37726695/ (added 22/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed cancer of the urinary tract with squamous cell carcinoma histology and without any TCC component
- •2. Mixed non-TCC histology is allowed if squamous cell carcinoma is the predominant histology
- •3. Newly diagnosed or progressive measurable disease as defined by RECIST version 1.1
- •4. To be considered measurable (and to be designated as a target lesion), a lesion must not have been treated with prior radiotherapy or focal ablation techniques
- •5. Suitable, in the judgment of the local investigator, for treatment with atezolizumab, with palliative intent
- •6. Adequate haematologic and end-organ function within 28 days prior to the first study treatment including:
- •6.1. Absolute neutrophil count =1.5 x 10e9/l
- •6.2. Platelet count =100 x 10e9/l
- •6.3. Haemoglobin =90 g/l
- •6.4. Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase =2.5 times the institutional upper limit of normal (ULN)
- •6.5. Total bilirubin =1.5 times ULN (or =3 ULN in patients with Gilbert’s syndrome)
- •6.6. Calculated creatinine clearance =20 ml/min (Cockcroft-Gault formula)
- •7. Up to one prior line of systemic chemotherapy for UTSCC
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •8. Life expectancy =12 weeks
- •9. Representative formalin-fixed paraffin-embedded (FFPE) tumour sample with an associated linked anonymised pathology report that is available for central use in translational studies
- •10. Able to comply with all trial procedures and processes
- •11. Age =18 years at time of signed informed consent form
- •12. Provision of written informed consent
排除标准
- •1. Any component of TCC histology
- •2. Planned for treatment with curative intent
- •3. Prior systemic immunotherapy (prior intra-vesical treatments are allowed) AURORA Protocol Version 2 03-MAY-2022 Page 21 of 51
- •4. Major surgery within 30 days prior to enrolment
- •5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •6. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- •7. Use of oral or IV steroids for 14 days prior to enrolment
- •8. Use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone) is allowed
- •9. Administration of a live or attenuated vaccine within 4 weeks prior to enrolment (COVID-19 vaccination is allowed)
- •10. Treatment with any other investigational agent within 4 weeks prior to enrolment
- •11. Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable arrhythmias, unstable angina or congestive cardiac failure (New York Heart Association =grade 2) within 6 months prior to enrolment
- •12. Patients with known HIV infection or with active tuberculosis
- •13. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test) or hepatitis C
- •14. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible
- •15. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- •16. Autoimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- •17. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study
- •18. History of idiopathic pulmonary fibrosis,organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •19. A history of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •20. Prior allogeneic stem cell or solid organ transplant
- •21. Patients who are pregnant or breastfeeding
- •22. Patients of childbearing potential who are not able to use a highly effective method of contraception (as detailed in section 3.7)
- •23. A recent or current other cancer
- •24. Current non-melanoma skin cancer, cervical carcinoma in situ or localized prostate cancer not requiring current treatment are permissible, as is a history of a separate other malignancy having completed all active treatment =2 years previously
研究者
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