GO29294 Anti-PDL1 Bladder Cancer Phase III Version 1.0
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, MULTICENTRE, RANDOMISED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY.
IRAS ID
161154
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-003231-19
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Urothelial Bladder Cancer (UBC) is the most common urinary system cancer worldwide and the seventh most common of all cancers in the UK. 10,000 people are diagnosed with bladder cancer each year in the UK and the overall 5 year survival rate for those with metastatic UBC is approximately 5.4%.
Cisplatin-based combination chemotherapy is the preferred therapy for patients with metastatic UBC. Nonetheless, a significant number of patients are not appropriate for this type of treatment. For cisplatin-ineligble patients, treatment options include carboplatin-based, non-platinum-based, single-agent chemotherapy regimens or even best supportive care (BSC).
Despite the limited survival benefit conferred by cytotoxic chemotherapy, platinum based regimens remain the standard first line option for most patients with locally advanced and metastatic UBC. These regimens are often associated with substantial side effects and are generally poorly tolerated by elderly and poor performance-status patients. Therefore, there is a significant unmet clinical need for an improvement to the therapy options for these patients.
This study aims to discover whether MPDL3280A offers an improved survival rate compared to chemotherapy for patients with advanced or metastatic UBC who have previously progressed during or following a platinum containing treatment. MPDL3280A is an antibody which is designed to help the bodies existing immune system identify and remove tumour cells more effectively.
A total of approximately 767 patients will be recruited into this study globally. Half the participants will receive MPDL3280A as an infusion once every 3 weeks and the other half will receive one of three existing chemotherapies. All patients will be treated until their disease worsens and then followed up every 3 months until the end of the study.
In the UK, it is expected that 75 participants will be enrolled across 18 study centres.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1798
Date of REC Opinion
21 Oct 2014
REC opinion
Favourable Opinion