
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial is looking at a new drug called sacituzumab govitecan on its own or in combination with other cancer treatments for urinary tract cancer.
It is for people who have urinary tract cancer that:
The lining of the urinary tract is called the urothelium, so cancer of the urinary tract can also be called urothelial cancer.
Urothelial cancer is a type of bladder cancer. Urinary tract cancer can start in the:
Doctors are looking for ways to improve treatment for people with urinary tract cancer that has spread. In this trial they are looking at adding sacituzumab govitecan to other cancer drugs.
Sacituzumab govitecan is a new drug for urinary tract cancer. It is a combination of 2 drugs:
The other cancer drugs in this trial include:
Immunotherapies stimulate the to find and kill cancer cells. This can slow down or stop the growth of the cancer. You might have avelumab for urinary tract cancer. Both zimberelimab and domvanalimab are currently being looked at for urinary tract cancer.
There are 3 treatment groups open in the UK. The group you join depends on the treatments you have had in the past. And which treatment you might be suitable for in this trial.
The main aims of the trial are to find out:
Please note, there are several treatment groups so the entry conditions for this trial are complex. Each group has specific entry conditions and we haven’t listed them all.
The trial team check if you are suitable to take part in the trial and which group you might join. The group you take part in depends on:
The following bullet points summarise some of the main . Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join the trial if all of the following apply. You:
As well as the above there are specific entry conditions for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial. |
Who cannot take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
As well as the above there are specific entry conditions and exclusion criteria for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial. |
This phase 2 trial is taking place worldwide. The trial team need 643 people to take part.
There are 6 groups in this trial. 3 groups are open in the UK, and we have included only information about these groups. Your doctor will tell you about the treatment group you might be suitable to join.
Depending on your treatment group, you may have a certain number of treatments. If this is the case, the number of treatments are described below. With all the other groups, you have treatment for as long as it is working, and the side effects aren’t too bad.
You have . Each cycle lasts for 3 weeks.
You stop treatment if your cancer gets worse. The trial doctor will talk to you about other treatment options.
Group 4
This group is open to people who haven’t yet had chemotherapy that included a such as cisplatin.
To begin with, you have 4 to 6 cycles of cisplatin and sacituzumab govitecan. This is called .
If your cancer doesn’t get worse after induction treatment you have . The aim is to keep the cancer under control. Some people have:
And some people have:
Maintenance treatment starts about 4 to 6 weeks after the last dose of induction treatment.
Group 5
Group 5 is open to people who have had 4 to 6 cycles of gemcitabine and cisplatin chemotherapy before joining this trial and:
To begin with, the first 6 to 8 people have sacituzumab govitecan and zimberelimab.
Once this part of the trial is finished and the team think it is safe to continue, the next part is randomised. A computer puts those taking part into a treatment group. There are 3 groups.
You have one of the following:
Group 6
This group is open to people who can’t have cisplatin chemotherapy.
To begin with 6 to 8 people have sacituzumab govitecan and zimberelimab.
The next 6 to 8 people have sacituzumab govitecan, zimberelimab, and domvanalimab.
Once these parts of the trial are finished and the team think it is safe to continue, the next part of the trial is randomised. A computer puts those joining the randomised part into a treatment group. There are 4 groups.
You have one of the following:
Samples for research
The researchers might ask you to give a sample of cancer tissue if there isn’t already a suitable one they can access. 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:
You see the doctor and have tests before you can take part. These include:
Treatment and how you have it
You have all your treatment at the hospital in the outpatient department.
Everyone taking part has cycles of treatment that last 3 weeks. The first day of each cycle is called day 1. You have all your treatment as a drip into a vein.
You have:
Check ups and trial scans
You see the trial doctor for regular check ups and blood tests.
You have a CT scan or MRI scan every 6 weeks for the first 3 months and then every 9 weeks. You have the trial scans until your cancer gets worse.
Follow up
You see the team one month after you stop treatment. After that they contact you every 3 months for up to 2 years. This might be at a routine hospital appointment, or they may call you to see how you are getting on.
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.
Zimberelimab, domvanalimab, and avelumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of zimberelimab include:
The common side effects of domvanalimab include:
The most common side effects of sacituzumab govitecan include:
You might have more severe side effects with combinations and your doctor will talk to you about this. You’ll have a chance to ask any questions you may have.
We have more information about the following drugs and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Thomas Powles
Gilead
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.