Urothelial Carcinoma
Conditions
Brief summary
The objective of this study is to investigate the effectiveness of Atezolizumab with a primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility
Interventions
Atezolizumab is administered via IV 1200 mg every 3 weeks
Sponsors
Study design
Eligibility
Inclusion criteria
* Metastatic UC (Urothelial Carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra * Will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic UC, per the decision of the treating physician * Have adequate hematologic and end-organ functions * Have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic UC and are clinically ineligible (unfit) for cisplatin-based chemotherapy
Exclusion criteria
* Have received prior immune checkpoint therapy * Are pregnant or breastfeeding * Are included in any other trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Rate (OS rate) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Median Overall Survival (OS) | Initiation of study treatment until death or end of study, approximately 4 years |
| Median Progression Free Survival (PFS) | Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years) |
| Percentage of participants with adverse events | Up to approximately 4 years |
Countries
Germany