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A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

Non-Interventional Study To Investigate The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03399643
Acronym
Announce
Enrollment
22
Registered
2018-01-16
Start date
2017-12-28
Completion date
2019-01-28
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

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

DRUGAtezolizumab

Atezolizumab is administered via IV 1200 mg every 3 weeks

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Overall Survival Rate (OS rate)2 years

Secondary

MeasureTime 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 eventsUp to approximately 4 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026