rare histological subtypes) and upper urinary tract (high grade or high risk), Tumours of the urothelial tract requiring surgery (T1 high grade-T4a of the bladder
Conditions
Brief summary
This study has a clinical and a biological primary endpoint: Clinical: • Bladder Cohort rare histological subtypes: To assess the efficacy of atezolizumab pre-cystectomy with respect to pCR rate in patients with carcinoma of the urothelium of the bladder (T1 high grade-T4aN0-1M0) with mixed or rare histological subtypes • UTUC Cohort: To assess the efficacy of atezolizumab pre-surgery with respect to pCR rate in patients with high grade or high risk (N0-1M0) upper urinary tract urothelial ca
Detailed description
1).To evaluate the safety and tolerability of atezolizumab when given in neoadjuvant treatment, 2) To assess the efficacy of atezolizumab given in the neoadjuvant setting before radical surgery with respect to anti-tumour effects as measured by Investigator assessed radiological response (RR)., 3) To assess the efficacy of atezolizumab given in the neoadjuvant setting before radical surgery with respect to antitumour effects based on Investigator assessed disease-free survival (DFS)., 4) To assess the efficacy of atezolizumab given in the neoadjuvant setting before radical surgery with respect to overall survival (OS).
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Queen Mary University Of London
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has a clinical and a biological primary endpoint: Clinical: • Bladder Cohort rare histological subtypes: To assess the efficacy of atezolizumab pre-cystectomy with respect to pCR rate in patients with carcinoma of the urothelium of the bladder (T1 high grade-T4aN0-1M0) with mixed or rare histological subtypes • UTUC Cohort: To assess the efficacy of atezolizumab pre-surgery with respect to pCR rate in patients with high grade or high risk (N0-1M0) upper urinary tract urothelial ca | — |
Secondary
| Measure | Time frame |
|---|---|
| 1).To evaluate the safety and tolerability of atezolizumab when given in neoadjuvant treatment, 2) To assess the efficacy of atezolizumab given in the neoadjuvant setting before radical surgery with respect to anti-tumour effects as measured by Investigator assessed radiological response (RR)., 3) To assess the efficacy of atezolizumab given in the neoadjuvant setting before radical surgery with respect to antitumour effects based on Investigator assessed disease-free survival (DFS)., 4) To assess the efficacy of atezolizumab given in the neoadjuvant setting before radical surgery with respect to overall survival (OS). | — |
Countries
France, Spain
Outcome results
None listed