Urothelial Carcinoma
Conditions
Brief summary
The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.
Interventions
DRUGAtezolizumab
Atezolizumab will be administered via IV at a 1200-mg dose over 60 minutes every 3 weeks (to be reduced to 30 minutes every 3 weeks if the first dose is tolerated).
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT) * Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra). * Have received at least one dose of atezolizumab as per local label and clinical practice.
Exclusion criteria
* Contraindicated atezolizumab therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AE) | Up to approximately 2 years. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) | Up to approximately 2 years. |
| Duration of Response (DOR) | Up to approximately 2 years. |
| Progression Free Survival (PFS) | Up to approximately 2 years. |
| Overall Survival (OS) | Up to approximately 2 years. |
Countries
Argentina
Outcome results
None listed