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

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 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 ) 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 , mTOR inhibitors  or immunotherapy
• 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 , in situ carcinoma  of the cervix and prostate cancer  where the PSA  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 ) 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  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.
• You have had treatment for a peptic ulcer 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  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 . This could be because you have a pacemaker, metal implants, a tube in your heart (coronary stent ) 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 ) 
• 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 ) 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 ) 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  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  within 30 days of starting treatment