OncoMatch/Clinical Trials/NCT04624399
Neoadjuvant Immune Checkpoint Inhibitor Treatment in Urothelial Cancer
Is NCT04624399 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Atezolizumab for urogenital cancer.
Treatment: Atezolizumab — This study is being carried out to see if the drug atezolizumab can reduce the size of tumours in patients with types of urothelial cancer before surgery. Atezolizumab is designed to stop a protein called PD-L1 (programmed death-ligand 1) being expressed on the cancer, allowing the immune system to recognise the tumour cells as foreign bodies and attack them. Atezolizumab has been shown to have activity in urothelial cancer which has spread. There two cohorts for this trial. One cohort will investigate the most common histological type of urothelial cancer (transitional cell carcinoma) outside the bladder, for example in the upper urinary tract. The other cohort will investigate rarer histological subtypes (such as such as squamous cell or adenocarcinoma) of urothelial cancer throughout the entire urinary system. This study will be recruiting patients from hospitals in the UK, France and Spain. If a patient is eligible for the study and decides to take part, they will receive up to two 3-weekly cycles of atezolizumab. 4-8 weeks after being enrolled, the patient will have an operation to remove the bladder (cystectomy) or the kidney, ureter and part of the bladder (nephroureterectomy or distal ureteral resection) as per normal practice. Following surgery, they will attend three hospital visits (4,12 and 24 weeks after surgery) and their disease progress/survival will be followed over the next 2 years. The clinical team will compare the patient's tumour tissue samples,scan results and blood results from before and after treatment with atezolizumab in order to see how well the drug works and if it is safe. Many of the procedures involved in this study are offered as standard care and participation in this trial will not delay surgery.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage T1 HIGH GRADE (TNM)
Grade: high grade or high risk
carcinoma of the urothelium (T1 high grade -T4a) in the bladder; high grade or high risk upper urinary tract urothelial carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: intravenous chemotherapy
Previously intravenous chemotherapy for urothelial cancer
Lab requirements
Blood counts
ANC ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1); WBC counts > 2500/μL; Lymphocyte count ≥ 500/μL; Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1); Haemoglobin ≥ 9.0 g/dL (patients may be transfused or receive erythropoietic treatment to meet this criterion)
Kidney function
Calculated creatinine clearance ≥ 20 mL/min (Cockcroft-Gault formula)
Liver function
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)
Adequate hematologic and end-organ function within 4 weeks prior to the first study treatment defined by the following: ... (see details above)
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