A trial comparing pembrolizumab and chemotherapy 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
Transitional cell cancer

Status:

Closed

Phase:

Phase 3

This trial is comparing pembrolizumab with chemotherapy for cancer of the urinary tract that has come back or continued to grow despite treatment.

The cancer may have spread elsewhere in your 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 and chemotherapy using platinum drugs Open a glossary item but sometimes the cancer can come back after treatment or continue to grow and sometimes spread elsewhere in the body. In this situation doctors may use a different type of chemotherapy. The types they most commonly use are

But they want to see if another type of drug such as pembrolizumab would be better. 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 find out

  • If pembrolizumab is a better treatment than the chemotherapy drugs
  • More about the side effects of pembrolizumab
  • How treatment affects your day to day life

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 has continued to grow or come back despite treatment, or that has spread elsewhere in the body
  • Have cancer that is mainly a type called transitional cell cancer
  • Have cancer that can be measured on a scan
  • Have had cisplatin or carboplatin chemotherapy in the past
  • 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 6 months afterwards if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

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

  • Are able to have a treatment just to the area where your cancer is that could cure your cancer for example surgery or radiotherapy
  • Have already had  paclitaxel
  • Have already had docetaxel
  • Have already had vinflunine
  • Are already taking part in a clinical trial or research study or have had an experimental treatment in the last 4 weeks
  • Have been diagnosed with a condition or have had a treatment that affects your immune system in the last 7 days (certain steroid therapy may be allowed, your doctor can advise you)
  • Have had treatment with 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 not recovered from any major surgery
  • 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 3 months (some other types of drugs are allowed and your doctor can advise you)
  • Have had a heart attack or angina that is not well controlled in the last 6 months, or problems with the rhythm of your heart requiring drugs, or problems with the blood flow to your heart (congestive heart failure)
  • Have a lung condition called interstitial lung disease
  • Have an infection which needs treatment
  • Have HIV, hepatitis B or hepatitis C
  • Are sensitive or allergic to paclitaxel, docetaxel or vinflunine or any similar drugs (your doctor can advise you about this)
  • Take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
  • 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 3 trial. The doctors need around 470 people to take part. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide whether you have pembrolizumab or chemotherapy.

You have either

  • Pembrolizumab

Or one of the following chemotherapy drugs

Your doctor decides which chemotherapy drug will be best for you.

Whichever group you are in, you have treatment through a drip into a 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 if you cope well with the treatment and your cancer does not grow then you could have treatment for up to 2 years.

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.

The trial team will also ask for a sample of tissue taken when your cancer was diagnosed. If this is not available then you will need to have a tissue sample (biopsy Open a glossary item) taken. They will also ask for extra blood samples for research.

Hospital visits

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

You go to the hospital once every 3 weeks for treatment. At these visits you will have a physical examination and blood tests. 9 weeks after you start treatment you have a CT scan. You will also have an 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. If this is the case they will discuss this with you.

After you finish treatment the doctors will see you about a month later. Then you see them every 6 weeks for the first year and every 3 months after that.

If your cancer gets worse or you start a new cancer treatment the trial team will either see you at the hospital every 3 months or will telephone you 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

There are other side effects of pembrolizumab that the trial team can advise you about.

The most common side effects of docetaxel are

  • Taste changes
  • Shortness of breath
  • Constipation
  • Loss of appetite
  • Discoloured fingernails or toenails
  • Swelling of your hands, face or feet
  • Tiredness and weakness (fatigue)
  • Joint and muscle pain
  • Feeling or being sick
  • Diarrhoea
  • Sore mouth
  • Hair loss
  • Skin rash
  • Watery and red eyes
  • Skin reactions at the site where the docetaxel goes into your vein such as redness, tenderness and swelling
  • Damage to the surrounding tissue if the docetaxel drip leaks.

The most common side effects of paclitaxel are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Hair loss
  • Numbness and tingling in your hands and feet (peripheral neuropathy)
  • Aching joints and muscles
  • Feeling or being sick
  • Allergic reaction
  • Diarrhoea
  • Sore mouth
  • Infections
  • Abnormal heart rhythm
  • Pain where the paclitaxel goes into your vein
  • Low blood pressure

The most common side effects of vinflunine are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Stomach pain
  • Feeling or being sick
  • Constipation
  • Diarrhoea
  • Sore mouth
  • Tiredness and weakness (fatigue)
  • Muscle pain
  • Weight loss
  • Loss of appetite
  • Hair loss
  • High temperature (fever)
  • Pain where the vinflunine goes in (IV site)

We have more information on

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

Dr Robert Jones

Supported by

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13123

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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