A trial of different types of drugs before surgery for kidney cancer (WIRE)

Cancer type:

Kidney cancer
Renal cell cancer

Status:

Open

Phase:

Phase 2

This trial is looking at 3 different drugs to have before surgery for kidney cancer. You have them either on their own or in combination.

It is open to people with a type of kidney cancer called clear cell renal cancer who can have surgery to remove it.

More about this trial

The standard treatment for kidney cancer is surgery to remove cancer in the kidney. This might be taking out the whole kidney (nephrectomy) or part of the kidney (partial nephrectomy). Sometimes people have further treatment with cancer drugs after their surgery. You usually don’t have cancer drugs before surgery. 

In this trial you will have drugs before surgery. The drugs they are looking at target different parts of cancer cells and can reduce the size of the cancer. You would normally have these drugs for longer than you will in this trial. So the researchers don’t think they will make the cancer smaller. But they think it will give them important information about how they work on the cancer cells. This will help in testing these drugs in future clinical trials. 

There are 3 drugs. Depending on when you join this trial you might get 1 of these drugs or a combination of them. The drugs are:

Cediranib is a cancer growth blocker called a tyrosine kinase inhibitor (TKI). It works by blocking the protein tyrosine kinase that cancer cells need to grow and multiply. 

Durvalumab is an immunotherapy. It works by helping the body’s immune system Open a glossary item fight cancer. 

Olaparib is a targeted drug Open a glossary item called a PARP inhibitor. PARP is a protein that helps damaged cells repair themselves. By blocking PARP cancer cells can’t repair themselves and so they die. 

As a part of the trial you give samples of cancer tissue (biopsies Open a glossary item) and have scans Open a glossary item done. 

The aim of this trial is to look at these tissue samples and scans to find out if these drugs or combination of drugs might work for kidney cancer. 

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 had a tissue sample (biopsy) showing that you have clear cell renal cancer. If you have not already had a biopsy, you will need to have one taken to be able to join in the trial.
  • can have surgery to remove all or part of your kidney 
  • have cancer that measures at least 4cm across. The cancer may or may not have spread to the nearby lymph nodes Open a glossary item or to another part of the body.
  • have at least 1 area of cancer that can be measured on a scan
  • have satisfactory blood test results
  • are fully active but might not be able to do heavy physical work (performance status 0 or 1)
  • are willing to use contraception during treatment and for 3 months after 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 your brain or the tissue covering the brain 
  • have cancer that is pressing against your spinal cord (spinal cord compression Open a glossary item) unless it has been successfully treated and there hasn’t been a sign of it getting worse for 28 days before starting trial treatment
  • have already had similar drugs such as PARP inhibitors, tyrosine kinase inhibitors Open a glossary item, mTOR inhibitors Open a glossary item or immunotherapy Open a glossary item
  • have had another cancer in the past 2 years apart from cancers that have a low risk of spreading and have been treated with the aim to cure such as non melanoma skin cancer Open a glossary item, in situ carcinoma Open a glossary item of the cervix and prostate cancer Open a glossary item where the PSA Open a glossary item shows the cancer isn’t growing or early prostate cancer that hasn’t been treated but is being watched closely (active surveillance)
  • are having other cancer treatment such as chemotherapy. If you have had other cancer treatment it must have finished at least 28 days before starting treatment in this trial.
  • can’t have cediranib, olaparib, durvalumab or similar drugs
  • have ongoing moderate to severe side effects from previous cancer treatment apart from hair loss (alopecia) and white patches on the skin (vitiligo)
  • have had a bone marrow transplant from another person (allogenic transplant Open a glossary item) or a double umbilical blood transfusion 

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

  • You weigh 30kg (4½st) or less.
  • Your body can’t absorb or breakdown certain sugars such as lactose and galactose.
  • You have had major surgery within 4 weeks of starting treatment unless you have fully recovered from it. For minor surgery it is 2 weeks.
  • You are taking an experimental drug or using an experimental device as part of another clinical trial.
  • You are either feeling or being sick and medicines can’t control it.
  • You can’t swallow tablets or capsules.
  • You have a problem with your digestive system Open a glossary item that affects how well your body absorbs medicines. This includes surgery such as removal of part of the stomach or bowel.
  • You have a feeding tube such as a nasogastric tube. Open a glossary item
  • You have had treatment for a peptic ulcer Open a glossary item within 6 months of starting treatment.
  • You have bleeding in the digestive system within 3 months of starting treatment.
  • You had a heart attack or symptoms of congestive heart failure in the past year.
  • You had chest pain (angina) that doesn’t have a pattern and can happen when resting in the past year.
  • You had heart surgery in the past year.
  • You had a blood clot in your arteries in the past year.
  • You had a stroke or mini stroke (TIA) in the past year.
  • You are taking medication that damps down your immune system Open a glossary item within 28 days of starting treatment apart from inhalers, creams or nasal sprays. If you are taking steroids the dose must be equal to 10mg or less of prednisolone per day.
  • You have HIV or any other disease that affects your immune system.
  • You have an active infection of tuberculosis (TB), hepatitis B or hepatitis C.
  • You have any other medical condition or mental health problem that your doctor or the trial team think will affect you taking part.

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

  • can’t have an MRI scan Open a glossary item. This could be because you have a pacemaker, metal implants, a tube in your heart (coronary stent Open a glossary item) to open a blockage or you are claustrophobic
  • are pregnant or breastfeeding

There are other reasons why you might not be able to have one of the treatments used in the trial. 

Cediranib and olaparib 
You cannot have cediranib or olaparib if any of the following apply. You:

  • taking medication that affects the CYP enzymes
  • have an abnormal heart trace (ECG Open a glossary item
  • are taking medication to correct an irregular heartbeat
  • have high blood pressure that is not well controlled 
  • have signs or symptoms of a blocked bowel within 3 months of starting treatment
  • had a collection of puss or infected fluid (abscess) in the tissue of your tummy within 3 months of starting treatment
  • have had an abnormal opening (fistula Open a glossary item) in your gut (digestive system). You might be able to have cediranib and olaparib if you had surgery to repair the opening and there hasn’t been any sign of the opening happening again within the 6 months before starting treatment.
  • have a heart scan (ECHO Open a glossary item) that shows your heart isn't pumping blood well enough 

Durvalumab
You cannot have durvalumab if any of the following apply. You:

  • have or had an autoimmune disease Open a glossary item apart from vitiligo. You might be able to have durvalumab if have coeliac disease controlled by diet only, have a thyroid that isn’t working well enough and are taking hormone replacements for it. Or your autoimmune disease hasn’t been active for the past 5 years.
  • have a live vaccine Open a glossary item within 30 days of starting treatment

Trial design

This is a phase 2 trial. The team need up to 76 people to join. 

You have treatment while you are waiting to have surgery. Depending on when you join the trial you might have one of the following:

  • cediranib
  • cediranib and olaparib
  • olaparib
  • durvalumab
  • durvalumab and olaparib

Cediranib is a tablet. You take it once a day every day for at least 2 weeks till 36 hours (1½ days) before surgery. 

Olaparib is a tablet. You take it twice a day every day for at least 2 weeks until the morning of surgery. 

You have a diary to write down when you have your tablets and how many. You must bring this with you when you go to a hospital appointment. 

You have durvalumab as a drip into a vein. You have it once at least 2 weeks before surgery. You have durvalumab at the hospital. It takes an hour to have. 

Research samples
The research team take a small piece of tissue (biopsy) when you join the trial. This is to confirm that your kidney cancer is a clear cell renal cancer. 

You give blood samples and urine samples:

  • when you join
  • during treatment
  • after treatment

Researchers use these samples to find:

  • what happens to these drugs in the body
  • how these drugs affect the body
  • out more about clear cell renal cancer

MRI scan study

The team might ask you to have a scan called a hyperpolarised MRI scan. As part of the scan you have an injection of a contrast fluid Open a glossary item. This can help the team see the cancer better and to find out how well treatment is working. 

If you are having the hyperploarised MRI scan the team might ask to have another injection of the contrast fluid soon after the first. 

By doing another injection and scan they want to show that the results of each are they same.  

You don't have to agree to this. You can still take part in the trial. 

Hospital visits

You see the doctor to have tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • urine test
  • heart trace (ECG Open a glossary item)
  • DCE-MRI scan
  • CT scan if not done in the month before joining. Your doctor will tell you if you need another CT scan.
  • sample of cancer tissue (biopsy)

You see the doctor when you start treatment and 2 weeks later for:

  • blood tests
  • urine test
  • heart trace

After surgery you see the doctor at 6 weeks to see how you are and for:

  • blood tests
  • urine test

You then see the doctor at 3 months for:

  • urine test
  • blood tests
  • CT scan

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 as soon as possible that you are on or have been on an immunotherapy. 

The most common side effects of durvalumab are:

  • tummy (abdominal) pain
  • changes to blood test results such as how well your liver Open a glossary item or pancreas Open a glossary item is working 
  • bruising and or pain at the cannula site
  • cough
  • loss of appetite 
  • diarrhoea
  • feeling dizzy
  • feeling sick (nausea)
  • high temperature (fever)
  • itching, rash
  • lung infection
  • shortness of breath
  • tiredness and or feeling weak (fatigue)

The most common side effects of cediranib are:

  • high blood pressure
  • loss of appetite and weight loss
  • diarrhoea
  • feeling dizzy
  • feeling sick
  • headache
  • changes to the voice – rough and husky (hoarse)
  • itching, rash
  • dry or sore mouth
  • changes to how the thyroid works
  • tiredness and or weakness
  • protein in the urine

The most common side effects of olaparib are:

  • tummy (abdominal) pain
  • changes to blood test results such as the blood count Open a glossary item
  • cough
  • loss of appetite
  • diarrhoea
  • feeling dizzy
  • feeling sick
  • headaches
  • shortness of breath
  • tiredness and or feeling weak
  • muscle and joint pain

Your doctor or a member of the trial team will talk to you about the possible side effects of the treatments before you agree to take part.

We have more information about:

Location

Cambridge
Glasgow

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 Grant Stewart

Supported by

Cambridge University Foundation Hospital Trust
University of Cambridge
AstraZeneca
Cancer Research UK Cambridge Centre

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16981

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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