A trial of atezolizumab for kidney cancer that has spread (CONTACT 03)

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

Cancer type:

Kidney cancer

Renal cell cancer

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is looking at adding a drug called atezolizumab to cabozantinib for kidney cancer.

It is open to people with kidney cancer that has spread to another part of the body or to the surrounding tissue. And it isn’t possible to remove it with surgery.

More about this trial

Cabozantinib is a treatment you might have if your kidney cancer has spread to another part of your body. This is advanced kidney cancer. Cabozantinib is a type of cancer growth blocker. It stops signals that cancer cells use to divide and grow.

Atezolizumab is an immunotherapy. It helps the immune system Open a glossary item to find and kill cancer cells. Researchers want to find out if adding it to cabozantinib slows cancer growth. But they aren’t sure so want to find out more.

Having atezolizumab and cabozantinib together is a new treatment. In this trial some people have atezolizumab and cabozantinib. And some have cabozantinib on its own.

The main aims of the trial are to:

find out how safe it is to have atezolizumab and cabozantinib together
find how well this combination of treatment works compared to cabozantinib on its own
learn more about the side effects
find out how treatment affects quality of life

Who can enter

The following bullet points are a summary of 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 a certain type of renal cell kidney cancer – either clear cell, papillary cell or sarcomatoid kidney cancer. Your doctor will know this.
have cancer that has spread to the surrounding tissue and it isn’t possible to remove it with surgery or it has spread elsewhere in the body
have cancer that got worse during or after having a type of immunotherapy called a checkpoint inhibitor. The team check which treatments you had and when you had them to see if you are suitable for the trial.
have cancer that your doctor can see and measure on a scan
have a sample of tissue (biopsy ) available for the trial team to do some tests on
can look after yourself but might not be able to do active work (Karnosfky performance score 70 to 100)
have satisfactory blood test results
are willing to use contraception during treatment and for a period of time after if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

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

You have had previous treatment for kidney cancer that included:

cabozantinib
more than 1 course of treatment with an immunotherapy drug such as pembrolizumab or nivolumab
more than 2 treatments for advanced kidney cancer
having an immunotherapy soon after surgery
having had a drug called rapamycin for advanced kidney cancer
recent radiotherapy

As well as the above the following can’t apply. You:

have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
have pain caused by cancer that isn’t well controlled with medication
have had another cancer that has got worse or needed treatment in the past 5 years. This is apart from successfully treated non melanoma skin cancer , carcinoma in situ (CIS) of the cervix, early prostate cancer, DCIS of the breast or early womb cancer.

Medical conditions

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

have areas of fluid on the lung, heart or tummy that need frequent draining
have had a heart attack, stroke or blood clot in the last 6 months or a significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial.
have an autoimmune condition that needs treatment apart from certain ones. Your doctor will know about this.
have had treatment to stimulate the immune system . This includes interferon in the last 2 weeks and if treatment hasn’t completely cleared your body.
have had treatment that damps down the immune system. This includes steroids within 2 weeks of starting trial treatments unless it was a low dose.
have scarring on the lungs or active inflammation of the lungs (pneumonitis )
have had a stem cell transplant or an organ transplant
have had recent major surgery
have high levels of calcium in the blood and treatment for this isn’t working
are taking drugs such as warfarin to thin your blood
have an increased risk of having a bleed
can’t swallow tablets
have an inherited condition and you can’t absorb sugars. Your doctor will know about this.
have had a fistula in your tummy or in the area around your throat
have a serious problem with your bowel such as a blockage
have high blood pressure that isn’t well controlled with medication
have a serious wound, ulcer or bone fracture that isn’t getting better
have HIV, an active hepatitis B or hepatitis C infection, active tuberculosis (TB) or any severe infection that needs treatment
have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part

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

have had a live vaccine within 4 weeks of starting treatment or you might need one during the trial
have had a severe allergic reaction to atezolizumab, cabozantinib or anything they contain
are pregnant or breastfeeding

Trial design

This phase 3 trial is taking place worldwide. The team need to find 500 people to take part including 30 from the UK.

It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.

You have 1 of the following:

cabozantinib
cabozantinib and atezolizumab

Diagram 1

Treatment
You have treatment in cycles Open a glossary item . Each 3 week period is a cycle of treatment.

You have atezolizumab as a drip into a vein. You have this once every 3 weeks.

Cabozantinib is a tablet. You take the tablets once a day. The trial doctor tells you how many to take and when to take them. You must not eat or drink anything for at least 2 hours before taking cabozantinib.

Everyone has treatment for as long as it is working and the side effects aren’t too bad.

Blood and tissue samples
The researchers ask you to give some extra tissue samples. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

see how well the treatment is working
look at genes to understand more about kidney cancer
look for substances called biomarkers to help work out why treatment might work for some people and not for others

You need to agree to give most of the samples to take part in the trial. There are a few you don’t need to agree to if you don’t want to. The team can let you know more about this.

Quality of life
The trial team ask you to fill out a questionnaire:

before you start treatment
at set times during treatment

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see a doctor and have some tests before you can take part in the trial. These include:

physical examination
heart trace
blood tests
urine tests
CT scan or MRI scan
bone scan

You may also need to give a tissue sample (biopsy Open a glossary item ).

During treatment you see the doctor every 3 weeks for a check up and blood tests. You have atezolizumab in the hospital outpatient department. Each treatment visit takes up to 3 hours.

You have a CT scan or an MRI scan:

every 9 weeks for the first 18 months and then
every 3 months until your cancer gets worse

You might also need to have bone scan at these time points. The team let you know if this applies to you.

When you finish treatment you see the doctor 1 month later for a check up.

Follow up
The team follow you up every 3 months when you finish treatment. You might see them at a routine hospital appointment or they may call you to see how you are getting on.

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.

Atezolizumab can affect the immune system. It may cause inflammation in different parts of the body. This 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 tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

The most common side effects of atezolizumab are: