A trial looking at pembrolizumab for people with urothelial (urinary tract) cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bladder cancer
Kidney cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at pembrolizumab for cancer of the urinary tract that can’t be removed with surgery, has come back after treatment, or has spread elsewhere in the body.

The urinary tract includes the

  • Centre of the kidney (renal pelvis)
  • Tube that takes urine from the kidney to the bladder (ureter)
  • Bladder
  • 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

Doctors often treat urothelial cancer with surgery. But sometimes the cancer can’t be removed from surgery, or it can come back after treatment and it can spread to other parts of the body.

In this situation doctors often use a chemotherapy drug called cisplatin. Some people cannot have cisplatin and so doctors want to see if another type of drug called pembrolizumab will work. Pembrolizumab is a type of biological therapy called a monoclonal antibody. It helps the immune system to kill cancer cells.

The aims of this trial are to

  • See if pembrolizumab works as a treatment for urothelial cancer
  • Find out more about the side effects of pembrolizumab

Who can enter

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

  • Have urothelial cancer of either the renal pelvis, ureter, bladder or urethra that cannot be removed with surgery, or that has come back after treatment, or spread elsewhere in the body
  • Have cancer that can be measured on a scan
  • Can have a sample of your cancer (a biopsy Open a glossary item) taken
  • Are not able to have cisplatin chemotherapy for some reason (the trial team can advise you about this)
  • Have satisfactory blood test results
  • Are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
  • Are willing to use reliable contraception during treatment and for up to 4 months afterwards if there is any chance that you or your partner could become pregnant
  • At least 18 years old

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

  • Have had platinum based chemotherapy for advanced urothelial cancer. If you had chemotherapy either before or after surgery to try to stop your cancer coming back, you may be able to take part if your cancer didn’t come back for at least a year
  • Are able to have a treatment just to the area where your cancer is that could cure your cancer for example surgery or radiotherapy
  • Are already taking part in a clinical trial or research study or have had an experimental treatment in the last 4 weeks
  • Have had  a monoclonal antibody in the last 4 weeks
  • Have not recovered from any side effects due to having had a monoclonal antibody in the past
  • Have had chemotherapy, other cancer drugs or radiotherapy in the last 2 weeks or you have not recovered from earlier treatment
  • Have had previous treatment with any anti-PD1 or anti- PD2 drugs (your doctors can advise you about this)
  • Have had a live vaccine in the last 30 days
  • Have another type of cancer except for non melanoma skin cancer that has been successfully treated carcinoma in situ of the cervix or early stage prostate cancer (your doctors can advise you about this)
  • Have cancer that has spread to your brain or spinal cord and is causing symptoms (you can take part if cancer spread to your brain was treated at least 4 weeks ago and is not causing symptoms)
  • Have inflammation of the covering of the brain (carcinomatous meningitis) caused by your cancer
  • Have problems with your immune system Open a glossary item making you more likely to get infections
  • Have an autoimmune disease Open a glossary item and have had drugs that suppress your immune system in the last 2 years. Some other types of drugs are allowed and your doctor can advise you
  • Have a lung condition called interstitial lung disease
  • Have an infection which needs treatment
  • Have HIV, hepatitis B or hepatitis C
  • Have any other medical condition or mental health problem that the trial team think could prevent you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The doctors need around 350 people to take part. Everybody taking part has pembrolizumab.

You have pembrolizumab through a drip into the vein once every 3 weeks. Each 3 week period is called a cycle of treatment. The doctors will tell you how many cycles of treatment you will have, but as long as the treatment is working you can have the drug for up to 2 years.

If you agree to take part, the trial team will ask for a tissue sample (biopsy Open a glossary item).You will have this before you start any treatment.

The trial team will ask you to fill out some questionnaires when you go for treatment. The questionnaires will ask about side effects and how you’ve been feeling. They are called quality of life studies.

Hospital visits

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

• Tissue sample (biopsy Open a glossary item)
• Physical examination
• Blood tests
• Urine tests
• Heart trace (ECG Open a glossary item)
• CT scan
• Bone scan
• MRI scan

You go to the hospital once every 3 weeks for treatment. At these visits you will have a physical examination and blood and urine tests. 9 weeks after you start treatment you have a CT scan. You will also have MRI scan and you may have a bone scan.  This is to see how well the treatment is working. After this you will have these scans very 6 weeks for the first year. Then you will have them every 3 months until your cancer gets worse. Your doctor may want you to have the scans more often and they will discuss this with you.

When you finish treatment you see the trial team about 1 month later. After that, you see them every 6 weeks for the first year and then every 3 months until your cancer grows or you start another treatment for your cancer.

If your cancer gets worse or you start a new cancer treatment the trial team will telephone you every 3 months to see how you are.

Side effects

Pembrolizumab is a new drug so not all the side effects may be known yet. The most common side effects of pembrolizumab are

We have information about the side effects of pembrolizumab.

Your doctor will talk to you about the possible side effects before you agree to take part in this trial.

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

Prof Thomas Powles

Supported by

Experimental Cancer Medicine Centre (ECMC)
Merck, Sharp & Dohme Limited (MSD)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13124

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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