Trial Design: This is an open-label, international, multi-centre window of opportunity phase II trial that aims to evaluate the effects of short-term preoperative therapy with atezolizumab in patients with histologically confirmed carcinoma of the urothelium in the bladder or upper urinary tract.
There are two patient cohorts in the study:
Eligible patients will receive 2 x 3 weekly cycles of atezolizumab before planned radical surgery with curative intent in the opinion of the investigator. Patients will attend study visits at 4, 12 and 24 weeks following their surgery. After the 24-week post-surgery visit, patients will enter a follow up phase during which they will be contacted annually for 2 years after their radical surgery to collect survival and disease status data. The efficacy of atezolizumab will be assessed on CT/MRI scan images, tumour tissue samples, blood and urine samples collected at baseline and after treatment with atezolizumab.
Chief Investigator: Prof T. Powles
Trial contact: firstname.lastname@example.org
Sponsor: Queen Mary University of London
Participating countries: UK, Spain, France
Source of funding: Hoffmann-La Roche Ltd (funding and study drug)