Muscle-Invasive Bladder cancer
Conditions
Brief summary
To assess event-free survival (EFS). Event’s components: clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event. Patients last known to be EFS event-free are censored at the date of last event-free cystoscopy and/or CT scan. Those patients without disease assessment who are still alive will be censored at date of inclusion in the trial
Detailed description
To assess clinical or pathological downstaging after SG + Zimberelimab treatment, To assess efficacy and safety of SG + Zimberelimab in unfit and unwilling to cystectomy UC patients, To determine the predictive role of biomarkers in tissue and blood in patients who achieve clinical or pathological downstaging after SG + Zimberelimab treatment
Interventions
DRUGZimberelimab
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
Fondazione IRCCS Istituto Nazionale Dei Tumori
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess event-free survival (EFS). Event’s components: clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event. Patients last known to be EFS event-free are censored at the date of last event-free cystoscopy and/or CT scan. Those patients without disease assessment who are still alive will be censored at date of inclusion in the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess clinical or pathological downstaging after SG + Zimberelimab treatment, To assess efficacy and safety of SG + Zimberelimab in unfit and unwilling to cystectomy UC patients, To determine the predictive role of biomarkers in tissue and blood in patients who achieve clinical or pathological downstaging after SG + Zimberelimab treatment | — |
Countries
Italy
Outcome results
None listed