ABACUS-2

Title: Phase II study of neoadjuvant immune checkpoint inhibitors in urothelial cancer

Disease site: Bladder and upper tract urinary cancer

Status: Open to recruitment

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:

• Bladder cohort: patients with (T1 high grade -T4a) carcinoma of the urothelium in the bladder with mixed or rare histological subtypes such as squamous cell or adenocarcinoma.
• UTUC cohort: patients with high grade or high risk upper urinary tract urothelial carcinoma (renal pelvis and ureter)

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.