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
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Atezolizumab 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). |
| DRUG | Bevacizumab | Bevacizumab 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03148418. Inclusion in this directory is not an endorsement.