A trial of chemotherapy and durvalumab for bladder cancer (NIAGRA)

Coronavirus and cancer

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Coronavirus and cancer

We know it’s a worrying time for people with cancer, we have information to help. If you have symptoms of cancer contact your doctor.

Read our information about coronavirus and cancer

Cancer type:

Bladder cancer

Status:

Open

Phase:

Phase 3

This trial is looking at adding durvalumab to chemotherapy for people with bladder cancer that has grown into the muscle wall. This is invasive bladder cancer. 

It is for people due to have surgery to remove their bladder. This surgery is called a cystectomy. 

More about this trial

Surgery to remove the bladder is the usual treatment for invasive bladder cancer. You might also have chemotherapy before and after surgery. But sometimes the cancer can come back. So researchers are looking for ways to improve treatment. In this trial they are looking at adding a drug called durvalumab. 

Durvalumab is a type of targeted drug called an immunotherapy. It seeks out cancer cells by looking for a certain protein and attaching to it. The immune system then recognises the marked cells and kills them.

Researchers think adding durvalumab will improve treatment. But they aren’t sure so want to find out more. In this trial, some people have chemotherapy and durvalumab. And some have chemotherapy only. Everyone has surgery. 

The main aims of the trial are to:

  • find out if adding durvalumab to chemotherapy works better than chemotherapy only
  • 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. 

Who can take part

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

  • have transitional cell or urinary bladder cancer that has grown into the muscle wall of the bladder but no further 
  • are well enough to have treatment before surgery to remove the bladder
  • are due to have an operation to remove the bladder
  • are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • weigh more than 30kg (4.7 stone)
  • have satisfactory blood test results  
  • are willing to use reliable contraception during treatment and for 3 months after durvalumab and 6 months after chemotherapy if there is any chance you or your partner could become pregnant 
  • are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related
You:

  • have cancer that has spread to the lymph nodes Open a glossary item or the area between the hip bones (pelvis) or tummy (abdomen)
  • have cancer that has spread elsewhere in the body
  • need to have an operation to remove the kidney or tubes that carry urine from the kidneys to the bladder (ureter)
  • have already had chemotherapy or immunotherapy in the past for bladder cancer that has grown into the muscle of the bladder (you might be able to join if you had BCG into the bladder
  • have cancer that can’t be removed with an operation
  • have had durvalumab and tremelimumab in the past
  • had or are having chemotherapy, a targeted drugs Open a glossary item, immunotherapy Open a glossary item or hormone treatment Open a glossary item
  • have had radiotherapy to the area between the hip bones (pelvis) within 2 years of joining the study
  • have side effects from past treatments that aren’t getting better apart from hair loss or loss of skin colour (vitiligo)
  • can’t have cisplatin because you have moderate hearing loss or numbness and tingling in your hands and feet
  • have had another cancer unless it was basal cell cancer Open a glossary item, squamous cell cancer Open a glossary item, carcinoma in situ  Open a glossary itemor any other cancer that you have had treatment for more than 5 years ago and there are no signs of it coming back
  • are taking part in another clinical trial 

Medical conditions
You:

  • had an organ transplant Open a glossary item and need to have medication to damp down the immune system Open a glossary item
  • have an autoimmune disease Open a glossary item such as colitis or Chron’s disease unless it is a skin condition called vitiligo, hair loss or problems with your thyroid gland Open a glossary item that are stable
  • had a heart attack in the last 6 months or you have other heart problems that need treatment 
  • have a problem with your immune system and it doesn’t work properly 
  • have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the last 2 weeks unless it was a very small dose, a cream or inhaler
  • have a condition called leptomeningeal carcinomatosis
  • have had surgery in the last month
  • have breathing problems due to inflammation and scarring of the lungs (a condition called interstitial lung disease)
  • have serious problems with your digestive system Open a glossary item that cause diarrhoea
  • have an active infection including tuberculosis, hepatitis B, hepatitis C or HIV
  • have any other medical condition or mental health problem that the trial team think would affect you taking part

Other
You: 

  • are pregnant or breastfeeding 
  • are allergic to any of the drugs in the trial 
  • have had a live vaccine Open a glossary item in the last 30 days
     

Trial design

This is an international phase 3 trial. Researchers hope that around 1,050 people will take part including 25 from the UK.
 
It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You have 1 of the following:

  • chemotherapy and durvalumab before surgery and more durvalumab after surgery (group 1)
  • chemotherapy only before surgery (group 2)


You have all your treatment as a drip into the bloodstream.

Everyone has chemotherapy treatment in cycles. Each cycle is 3 weeks. The first day of each cycle is called day 1. 

Chemotherapy and durvalumab (group 1)
You have 4 cycles of chemotherapy before surgery. 

You have:

  • cisplatin and gemcitabine on day 1 
  • durvalumab on day 1
  • cisplatin and gemcitabine on day 8

Treatment takes about 8 hours each time. 

Chemotherapy only (group 2)
You have 4 cycles of chemotherapy before surgery. 

You have:

  • cisplatin and gemcitabine on day 1
  • cisplatin and gemcitabine on day 8

Treatment takes about 4 hours each time. 

Both groups
Both groups then go on to have surgery as planned. The trial team will tell you more about this and how long you stay in hospital for afterwards. 

After surgery:

  • people in group 1 have durvalumab once a month for 8 months 
  • people in group 2 don’t have any more treatment – they have regular follow up for up to 8 months

You continue to have follow up as long as your cancer doesn’t get worse. 

Quality of life
The trial team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Blood tests 
You have extra blood tests as part of this trial. Researchers want to look for:

  • certain proteins Open a glossary item that can help to tell how well the treatment is working
  • find out what happens to the drugs inside your body Open a glossary item 
  • look at the cancer DNA Open a glossary item

Urine tests
You have extra urine tests to look for biomarkers Open a glossary item.

Tissue samples
The trial team ask to use a tissue sample your doctor took when you had surgery or a biopsy Open a glossary item. You need to give a new sample if there isn’t a suitable sample available. They also take a sample of tissue when you have surgery to remove the bladder.  
 
Researchers want to look for certain proteins (biomarkers) in the cancer. 

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • physical examination
  • blood samples
  • urine samples
  • heart trace Open a glossary item
  • CT scan or MRI scan

You have treatment in the hospital outpatient department. You shouldn’t need to stay overnight. 

You have an MRI or CT scan after surgery. You have them:

  • every 3 months for 2 years
  • every 6 months for the 3 years
  • once a year after that 

You have regular check ups with your doctor during and after treatment. When you finish treatment in group 1, you have a check up:

  • once a month for the first 3 months 
  • every 3 months up until the end of the first year after your surgery
  • every 6 months for 2 years 
  • once a year after that 

In group 2 you go to hospital for a check up 1 month and 3 months after surgery. The trial team contact you by phone in between these clinic visits to see how you are getting on. 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 
 
Durvalumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.

If you have any of these side effects, you should tell the doctor or nurse that you are on or have been on an immunotherapy. 

The most common side effects of durvalumab are:

  • diarrhoea
  • skin rashes, dry and itchy skin 
  • liver problems such as inflammation of the liver (hepatitis) and high levels of liver enzymes in your blood
  • tiredness
  • feeling or being sick
  • pain in your tummy (abdomen), muscles and joints
  • a build up of fluid in your body causing swelling 
  • chest infections, cough and shortness of breath 
  • loss of appetite 
  • high temperature (fever)

We have information about:

Location

Edinburgh
Liverpool
London
Nottingham
Sheffield

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 Tom Powles

Supported by

AstraZeneca

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16661

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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