
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is testing different treatments for different subtypes of urinary tract cancer. It is for people whose cancer has grown into surrounding tissues or spread elsewhere in the body (advanced cancer).
The urinary tract includes the:
Cancer Research UK supports this trial.
Chemotherapy is one of the usual treatments for advanced urothelial cancer. After chemotherapy, you have regular monitoring. This means you don’t have treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. If it does, then you and your doctor decide which treatment is best for you.
Researchers are looking at ways to delay the cancer growing again after chemotherapy. We know from research in other cancers that having more treatment (sometimes called maintenance therapy) can increase the time it takes for the cancer to come back. Researchers want to see if this also happens in people with advanced urinary tract cancer.
But not all urinary tract cancers are the same and some new cancer drugs may help people with one type of urinary tract cancer more than another.
To work out the subtype of urinary tract cancer you have, the researchers will test a sample of your cancer (biopsy) to look for changes to certain genes and proteins (biomarkers).
The trial team are testing a number of different treatments. In this trial you have 1 of the following:
They are all types of targeted cancer drugs.
Cabozantinib works in 2 different ways. It blocks particular proteins on cancer cells. These proteins encourage the cancer to grow. It also stops the cancer cells growing blood vessels, which the cells need to be able to grow. Researchers hope that cabozantinib might delay the cancer growing for a time.
Rucaparib is a type of treatment called a PARP-1 inhibitor. This means it blocks an enzyme called PARP-1 that helps damaged cells to repair themselves. PARP stands for poly ADP-ribose polymerase and is in all cells, including cancer cells.
Enzalutamide is a type of hormone therapy.
The overall aims of this trial are to find out:
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.
The main entry conditions to join the trial include all of the following.
You cannot join this trial if any of these apply.
As well as the above, there are separate entry conditions for:
This phase 2 trial is based in the UK. 3 parts of the trial are open. The researchers need 188 people to join.
In:
The doctors test a sample of your cancer taken when you had a previous biopsy or surgery. They will try to classify your cancer as a particular subtype. You have treatment according to the biomarker they find. Some people have cabozanitinib, rucaparib or enzalutamide. And some have a dummy drug.
Both 3 parts of the trial are randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will you know which group you are in. This is called a double blind trial.
Cabozantinib, rucaparib and the dummy drug are tablets. Enzalutamide and the dummy drug are capsules. The trial team will give you a fresh supply of medication every 4 weeks.
You have treatment as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
ATLANTIS-1
If you don’t have a specific biomarker being looked at (you are biomarker negative), you might be suitable to join this part of the trial.
You are put into 1 of 2 groups to have 1 of the following:
You take cabozantinib or the dummy drug once a day, everyday.
ATLANTIS-2
This part of the trial is for people who have a biomarker called HRD. This means you are HRD biomarker positive.
You are put into 1 of 2 groups to have 1 of the following:
You take rucaparib or the dummy drug, twice a day, everyday.
Research samples
The trial team will ask to take some extra blood samples as part of this trial. This is to look for biomarkers. Where possible, you have these at the same time as your routine blood tests.
Biomarkers help to predict who is most likely to benefit from this treatment and also help us to better understand advanced urinary tract cancers.
You don’t have to give these samples if you don’t want to. You can still take part in the trial.
You see a doctor and have some tests before you can take part. These include:
You see the trial team once a month for a check up and some blood tests. You have a CT scan or MRI scan every 3 months.
When you finish treatment you see the trial team:
The most common side effects of cabozantinib include:
You should avoid grapefruit and Seville oranges as they might increase the levels of cabozantinib in the body.
The most common side effects of rucaparib include:
There is also a small chance it might cause:
The trial team will talk to you about all the possible side effects before you agree to join.
We have more infromation about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Robert Jones
Professor Thomas Powles
Cancer Research UK
Clovis Oncology Inc
Exelixis
NHS Greater Glasgow and Clyde
University of Glasgow
Astellas Pharma Europe
This is Cancer Research UK trial number CRUK/12868.
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”