At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel, and 2 other interventions for Bladder Cancer. Completed, enrolled 931 participants across 217 sites in 29 countries.
Detailed Summary
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 931 participants.
Study Details
Timeline
Interventions
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
Paclitaxel 175 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
Vinflunine 320 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.