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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2017

At a glance

  • Drugs Atezolizumab (Primary) ; Docetaxel; Paclitaxel; Vinflunine
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms IMvigor 211
  • Sponsors Roche
  • Most Recent Events

    • 22 Sep 2017 According to a Roche media release, the European Commission (EC) has granted a marketing authorisation for TECENTRIQ (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic urothelial carcinoma who have been previously treated with a platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status. This approval is based on results from the IMvigor211 study and cohorts 1 and 2 from IMvigor210 study.
    • 21 Jul 2017 According to a Roche media release, data from this trial were presented at EACR-AACR-SIC Special Conference 2017.
    • 21 Jul 2017 According to a Roche media release, the CHMP adopted a positive opinion for the use of TECENTRIQ as a monotherapy. This positive opinion is based on results from the IMvigor211 study and cohorts 1 and 2 of the IMvigor210 study.
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