MEDI4736 and AZD4547 in treatment of advanced bladder cancer
Research type
Research Study
Full title
An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in patients with Muscle Invasive Bladder Cancer (MIBC) who have progressed on prior treatment (BISCAY)
IRAS ID
184374
Contact name
Thomas Powles
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-002228-25
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm Phase 1b study in patients with muscle invasive bladder cancer (urothelial) who have progressed on prior treatment. This study allows the evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents in patients with muscle invasive bladder cancer.
The study will consist of a number of study modules (substudies), each evaluating the safety and tolerability of a specific agent or combination. The initial module (Module A) incorporates an AZD4547 monotherapy arm and MEDI4736+AZD4547 combination therapy arm. Additional agents will be added as part of this multi-drug protocol as decisions on the most appropriate combinations to use become available. A substantial protocol amendment with relevant nonclinical and clinical data will be put in place before starting a new combination module.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/1760
Date of REC Opinion
2 Nov 2015
REC opinion
Favourable Opinion