A trial of nivolumab after surgery for urothelial cancer (urinary tract cancer) (CA209-274)

Cancer type:

Bladder cancer
Kidney cancer

Status:

Open

Phase:

Phase 3

This trial is for people with a high risk of their urinary tract cancer coming back after surgery.
 
The urinary tract includes the:

  • centre of the kidney Open a glossary item (renal pelvis)
  • tube that takes urine from the kidney to the bladder (ureter)
  • bladder Open a glossary item
  • tube that drains urine from the bladder and out of the body (urethra Open a glossary item

The lining of the urinary tract is called the urothelium Open a glossary item so cancer of the urinary tract can also be called urothelial cancer.

More about this trial

Surgery is the usual treatment for cancer of the urothelial tract. You might also have a chemotherapy drug called cisplatin before or after surgery. 

Some people have a higher risk of their cancer coming back. So doctors are looking for way to improve treatment for people in this situation. In this trial they are looking at a drug called nivolumab. 

Nivolumab is a type of biological therapy Open a glossary item called a monoclonal antibody. It helps the immune system Open a glossary item kill cancer cells. Doctors think it might help stop the cancer coming back. 

The aims of the trial are to:

  • find out how well nivolumab works
  • find out how safe it is
  • 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 might be able to join this trial if the following apply.

  • You have urothelial cancer that started in the middle of the kidney (the renal pelvis), ureter, bladder or urethra
  • Your cancer has a high risk of coming back because you are not having cisplatin before your surgery and you have

           o any size tumour that has spread to the lymph nodes but not to another part of the body or
           o a tumour that has grown through the muscle wall but not into the pelvic or abdominal wall or spread to lymph nodes. 

          And you aren’t suitable to have cisplatin after surgery or you are refusing it 

         OR you had cisplatin before surgery 

           o for any size tumour that has spread to the lymph nodes but not to another part of the body or
           for a tumour that has grown through the connective tissue and into the pelvic wall but hasn’t spread to the lymph nodes  

The following must also apply.

  • You had an operation within 4 months of joining the trial and the surgeon was able to remove all the cancer 
  • There is no sign of your cancer on a scan
  • Most of the cancer cells are a type called transitional cancer cells or urothelial cancer cells
  • There is a tissue sample (biopsy Open a glossary item) of your cancer available for the trial team to do some tests 
  • You are willing to use reliable contraception during treatment and for 6 months after the final dose of nivolumab if you are a woman, or 8 months if you are a man, if there is any possibility you or your partner could become pregnant
  • You have satisfactory blood test results
  • You are at least 18 years old

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

  • Have had part of your bladder removed for bladder cancer or part of your kidney removed for cancer that started in the middle of the kidney (the renal pelvis)
  • Have had surgery to remove a urinary tract cancer and then had a treatment that affects your whole body (systemic treatment) or radiotherapy for either urinary tract cancer or prostate cancer
  • Have had any anti cancer treatment including chemotherapy, radiotherapy, biological therapy or experimental treatment within 28 days of starting treatment in this trial
  • Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated
  • Have an autoimmune disease Open a glossary item unless it is vitiligo, type 1 diabetes, thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need systemic treatment
  • Have side effects from past treatment apart from minor kidney damage, numbness and tingling in your hands or feet (peripheral neuropathy), hearing loss, hair loss or tiredness (fatigue)
  • Have had a severe allergic reaction to monoclonal antibodies or immunotherapy Open a glossary item in the past 
  • Are allergic to nivolumab or anything it contains
  • Have taken steroids in the last 2 weeks to dampen down your immune system apart from inhalers, cream or steroids to replace hormones in the body
  • Have had had major surgery in the last 4 weeks or minor surgery such as a biopsy in the last 3 days
  • Have hepatitis B or hepatitis C
  • Have HIV or AIDS
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need 640 people to join including 20 from the UK. It is a randomised trial. You are put into 1 of 2 treatment groups by a computer:

Diagram showing trial randomisation

Neither you nor your doctor can decide which group you are in.

You have nivolumab as a drip into a vein every 2 weeks. It takes about 30 minutes. 

You continue to have nivolumab for up to a year as long as it is helping you and the side effects aren’t too bad. 

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

Blood tests 
You have some extra blood tests as part of this trial. The researchers want to find out what happens to nivolumab in the body.

They will also look for substances called biomarkers Open a glossary item to see why treatment works better for some people than others. 

Tissue samples
You may also need to give a tissue sample (biopsy) of your cancer before you start treatment. This is to check if there is a marker on your cancer called PD-L1. 

If you already had a tissue sample of your cancer taken either when you were diagnosed or during treatments, the trial team will ask to use some of it.

Hospital visits

You’ll see the doctors and have some tests before you start treatment. The tests include:

  • CT scan or MRI scan 
  • physical examination
  • a test to look inside your bladder (a cystoscopy Open a glossary item
  • blood and urine tests

You go to hospital every 2 weeks to have treatment. You see the trial team for a check up and some blood and urine tests. 

 You have a test to look inside your bladder (a cystoscopy) every 3 months (unless you have had your bladder removed).

When you stop treatment you see the trial team after:

  • 1 month
  • 3 months

The trial team continue to follow you up every 3 months to see how you are getting on. They will phone you or see you at a routine hospital appointment.

You have a CT or MRI scan every:

  • 3 months for 2 years
  • 4 months for the next 2 years
  • 6 months in the 5th year 

Side effects

The most common side effects of nivolumab are:

We have more information about nivolumab.

Location

Edinburgh
London
Manchester
Sheffield
Sutton

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 Robert Huddart

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14151

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think