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
- 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.