Trials / Terminated
TerminatedNCT02450331
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 809 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Atezolizumab will be administered at a dose of 1200 milligrams (mg). |
Timeline
- Start date
- 2015-10-05
- Primary completion
- 2019-11-30
- Completion
- 2022-06-14
- First posted
- 2015-05-21
- Last updated
- 2023-06-18
- Results posted
- 2020-11-18
Locations
186 sites across 24 countries: United States, Australia, Belgium, Canada, China, Czechia, Finland, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02450331. Inclusion in this directory is not an endorsement.