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

NCT02302807 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 931

Last updated 2019-08-01

Study results available
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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.

Conditions

Interventions

DRUG

Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

DRUG

Docetaxel

Docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

DRUG

Paclitaxel

Paclitaxel 175 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

DRUG

Vinflunine

Vinflunine 320 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-13
Primary Completion
2017-03-13
Completion
2018-11-08

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302807 on ClinicalTrials.gov