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Clinical trial

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

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Last updated:13th Jan 2015
Identifier: NCT02302807

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 932 participants.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Enrollment: 932
Actual Study Start Date: January 13, 2015
Estimated Study Completion Date: November 28, 2017
Primary Completion Date: March 13, 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Arm A: Atezolizumab
- Active Comparator: Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Category Value
Date last updated at source 2017-08-02
Study type(s) Interventional
Expected enrolment 932
Study start date 2015-01-13
Estimated primary completion date 2017-03-13

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