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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Urinary tract squamous cell carcinoma
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Background and study aims
Patients with urinary tract squamous cell carcinoma (UTSCC) cannot be cured with current treatments and do not have good survival outcomes compared to other cancers. This study is investigating whether PD-L1 inhibition with atezolizumab, an immunotherapy drug that is not currently licensed in Europe for UTSCC (but is licensed and used in other cancers), will allow patients with UTSCC to improve their survival rates.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37726695/ (added 22/09/2023)
You can take part if:
You may not be able to take part if:
1. Any component of TCC histology2. Planned for treatment with curative intent3. Prior systemic immunotherapy (prior intra-vesical treatments are allowed) AURORA Protocol Version 2 03-MAY-2022 Page 21 of 514. Major surgery within 30 days prior to enrolment5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins6. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation7. Use of oral or IV steroids for 14 days prior to enrolment8. Use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone) is allowed9. 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 enrolment11. 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 enrolment12. Patients with known HIV infection or with active tuberculosis13. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test) or hepatitis C14. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible15. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA16. 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 glomerulonephritis17. 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 study18. 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 scan19. A history of radiation pneumonitis in the radiation field (fibrosis) is permitted20. Prior allogeneic stem cell or solid organ transplant21. Patients who are pregnant or breastfeeding22. 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 cancer24. 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Simon
Crabb
S.J.Crabb@southampton.ac.uk
The study is sponsored by University Hospital Southampton NHS Foundation Trust and funded by Cancer Research UK; Grant Codes: CRCPJT\100018; Roche.
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Or CPMS 53225
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