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NCT02450331 · ClinicalTrials.gov registry record · Phase 3
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 809
- Enrollment target
NCT02450331: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02450331 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 809 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02450331, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 809 participants
- Enrollment target
Study 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.
Primary Outcome
DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Interventions
- DRUG Atezolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 809 participants |
| Start Date | 2015-10-05 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 3 |
Why NCT02450331 stopped before completion
NCT02450331 is an interventional study that assigns participants to a tested intervention. The registered 809 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Atezolizumab is the first listed.
NCT02450331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02450331 about?
NCT02450331 is a clinical study titled "A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection". 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...
What is the current status of trial NCT02450331?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 809 participants. The study started on 2015-10-05. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT02450331?
The interventions under investigation include: Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT02450331?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02450331's enrollment target sits among peer trials
809 410th of 2000 higher than 1,591 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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