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Active Not RecruitingNCT03782207

A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
2,756 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

Detailed description

The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible participants receiving atezolizumab as first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally advanced/metastatic UC). The study may be amended for inclusion of new cohorts as these are approved in the participating countries. Participants will be included into each cohort based on their indication for receiving atezolizumab.

Conditions

Interventions

TypeNameDescription
DRUGAtezolizumabAtezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.

Timeline

Start date
2019-02-07
Primary completion
2026-07-31
Completion
2026-07-31
First posted
2018-12-20
Last updated
2026-01-08

Locations

258 sites across 30 countries: Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Egypt, Estonia, France, Hungary, India, Italy, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Singapore, Slovenia, Spain, United Arab Emirates, United Kingdom

Source: ClinicalTrials.gov record NCT03782207. Inclusion in this directory is not an endorsement.