A trial looking at MPDL3280A before surgery for bladder cancer (ABACUS)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Open

Phase:

Phase 2

This trial is for people whose bladder cancer has spread beyond the inner lining of the bladder (invasive bladder cancer). Cancer Research UK supports this trial. 

More about this trial

Surgery is a treatment used for invasive bladder cancer. One of the operations usually done is a cystectomy (removal of the bladder).

MPDL3280A (also called atezolizumab) is a type of biological therapy called a monoclonal antibody. Cancer cells produce a particular protein called PD-L1. This helps the cancer cells to hide away from the immune system. MPDL3280A blocks PD-L1, allowing the immune system to recognise and kill the cancer cells. 

Earlier trials have looked at MPDL3280A in people whose cancer has spread elsewhere in the body. The cancer shrank in some of these people.

Doctors want to find out if it is useful in people with an earlier stage disease who are due to have surgery. 

The aims of this trial are to 

  • see whether MPDL3280A can reduce the size of the bladder cancer
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if all of the following apply.

  • You have transitional cell bladder cancer 
  • Your cancer has grown into the muscle layer of your bladder or beyond. But it has not spread to the wall of the abdomen or pelvis (stage T2 to T4 bladder cancer). And it has not spread into your lymph nodes Open a glossary item or anywhere else in your body
  • You still have bladder cancer following a Trans Urethral Resection of the Bladder (TURBT) and you are due to an operation to remove your bladder  
  • There is a sample of your bladder cancer available for testing by the trial team
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 3 months after finishing MPDL3280A if there is any chance that you could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have had major surgery in the last 4 weeks, or you need to have surgery (apart from a cystectomy) when you are due to have MPDL3280A
  • Have had chemotherapy through a drip into a vein for your bladder cancer
  • Have had treatment with immunotherapy Open a glossary item, such as interferon or interleukin in the last 4 weeks (this period of  time may vary depending on the drug)  
  • Have had a stem cell transplant using the stem cells of a donor (allogeneic transplant Open a glossary item)
  • Have had an organ transplant
  • Have already had treatment with drugs called CD137 agonists,CTLA-4 agonists or PD-L1 or PD-1 inhibitors
  • Have had a live vaccination in the last 4 weeks
  • Have had antibiotics, either as tablets or into a vein, in the last 2 weeks (you may be able to take part if you are having antibiotics to treat chronic obstructive pulmonary disease or to prevent urinary tract infection)
  • Have had steroids into a vein or as tablet in the last 2 weeks apart from inhalers or to treat conditions such as Addison’s disease
  • Have particular heart problems such as unstable angina, or a heart attack in the last 3 months
  • Have a lung condition called pulmonary fibrosis
  • Have a liver problems such as have scarring of the liver (cirrhosis) 
  • Have had a severe infection in the last 4 weeks
  • Have an autoimmune disease such as rheumatoid arthritis, inflammatory bowel disease, myasthenia gravis or systemic lupus erythematosus
  • Are HIV positive
  • Have active hepatitis B or C
  • Have poorly controlled type 1 diabetes mellitus (you can take part if your diabetes is well controlled using insulin)
  • Have tuberculosis which is causing symptoms (active TB)
  • Have a condition where there is too much calcium in your blood Open a glossary item and this is not stable, or you need continual treatment for this
  • Have a condition affecting your digestion, or you have had particular surgery, that could affect the absorption of MPDL3280A
  • Have had cancer in the last 5 years, unless it was very early stage and has been successfully treated 
  • Have any other medical condition that the trial doctor thinks could affect your taking part
  • Are pregnant or breast feeding 
  • Are allergic to the drugs used in this trial

Trial design

This is a phase 2 trial. The researchers need 85 people to join.

Everyone has MPDL3280A through a drip into a vein. You have this every 3 weeks. Each 3 week period is called a cycle of treatment and you have up to 2 cycles. 

You have surgery as planned after treatment with MPDL3280A. The timing of surgery will vary for different people in the trial. But it will be at least 5 days after your last cycle of MPDL3280A.

Having treatment with MPDL3280A should not affect your operation in any way. Or make it any more difficult. 

The trial team collect some samples of your cancer removed during your operation. These will be used to see what effect MPDL3280A has had on your cancer. Some samples will be stored and used in future research.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include 

  • Blood tests
  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan to measure your cancer
  • Urine tests

You see a trial doctor again

  • before each cycle of treatment
  • just before surgery
  • 1 month, 3 months and 6 months after surgery 

The doctor will check how you are, ask you about side effects and you have some blood and urine tests. 

As part of this trial, you have extra blood samples taken. You have these 

  • when you join the trial
  • before each cycle of treatment
  • before surgery
  • 1 month, 3 months and 6 months after surgery

Where possible these are taken at the same time as your routine blood tests. The trial team will look at these to see what happens to MPDL3280A in your body. 

The trial team will ask your permission to contact you 1 and 2 years after your operation. They can do this by phone. The researchers will ask how you are and about your health. It should only take about 5 minutes.

Side effects

The most common side effects of MPDL3280A include 

The risks or side effects following surgery include 

  • pain
  • infection
  • bleeding

We have more information about 

Location

London
Oxford
Southampton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Thomas Powles

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Queen Mary University of London

Other information

This is the Cancer Research UK trial number CRUKE/15/014

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13385

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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