ABACUS
Research type
Research Study
Full title
A phase II study investigating preoperative MPDL3280A in operable transitional cell carcinoma of the bladder
IRAS ID
178097
Contact name
Thomas Powles
Contact email
Sponsor organisation
Barts Health NHS Trust
Eudract number
2015-001112-35
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
This study is being carried out to see if the drug MPDL3280A can reduce the size of tumours in patients with bladder cancer before surgery. MPDL3280A is currently being investigated in a number of tumour types and has been shown to have activity in bladder cancer which has spread beyond the bladder.
MPDL3280A is designed to stop a protein called PD-L1 (programmed death-ligand 1) being expressed on the cancer. PD-L1 helps to camouflage the cancer, preventing the body’s immune system from identifying the cancer and fighting it. MDPL3280A works against PD-L1, allowing the immune system to recognise the tumour cells as foreign bodies and attack them.
There are strict inclusion and exclusion criteria for this trial. Broadly speaking, patients with histologically confirmed transitional cell carcinoma of the bladder (T2-T4a – this indicates how far into the bladder the cancer cells have grown) are eligible.
If a patient is eligible for the study and decides to take part, they will be enrolled into the study and will receive up to two 3-weekly cycles of MPDL3280A. 4-8 weeks after being enrolled, the patient will have an operation to remove the bladder (cystectomy) as per normal practise. Treatment with MPDL3280A in the window between enrolment and surgery will not delay this surgery. Following the operation, they will attend three hospital visits (4, 12 and 24 weeks after cystectomy) and their disease progress/survival will be followed over the next 2 years. The clinical team will compare the patient’s tumour tissue samples, scan results and blood results from before and after treatment with MPDL3280A in order to see how well the drug works and if it is safe. Many of the procedures involved in this study are offered as standard care and participation in this trial will not delay surgery.
The study is being carried out in England and will also take place in 5 other European countries (France, Germany, Italy, the Netherlands, Spain).
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1635
Date of REC Opinion
16 Oct 2015
REC opinion
Favourable Opinion