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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AE) | Up to approximately 2 years. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra) that have received the indication for treatment with atezolizumab as per local label (disease progression during or following platinum containing therapy) in the context of routine clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Productos Roche S.A. Quimica e Industrial, División Farmacéutica | Buenos Aires | B1610BAL | Argentina |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| Progression Free Survival (PFS) | Up to approximately 2 years. |
| Overall Survival (OS) | Up to approximately 2 years. |