Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT03148418

A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
382 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

Conditions

Interventions

TypeNameDescription
DRUGAtezolizumabAtezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
DRUGBevacizumabBevacizumab will be administered as directed per the parent study.

Timeline

Start date
2017-09-20
Primary completion
2030-03-06
Completion
2030-03-06
First posted
2017-05-11
Last updated
2026-04-13

Locations

170 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03148418. Inclusion in this directory is not an endorsement.