
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This study is looking at durvalumab in combination with the S-488210/S-488211 vaccine to treat non muscle invasive bladder cancer.
Doctors can treat non muscle invasive bladder cancer with:
Trans urethral removal of bladder cancer (TURBT) is usually the first treatment for non muscle invasive bladder cancer.
BCG is a type of . You have this directly into your bladder using a flexible tube (catheter). You usually have BCG if your bladder cancer is at a high risk of coming back or spreading.
When these treatments don’t work or your cancer comes back the is to remove the whole bladder (cystectomy).
Researchers think that other immunotherapies might work after BCG stops working. This is what the DURANCE study is looking at. In this case, doctors could then use these treatments instead of doing a cystectomy.
Durvalumab is an immunotherapy. Durvalumab works by stimulating the body’s to attack cancer cells. Doctors already use durvalumab to treat non small cell lung cancer. And researchers are also using it in clinical trials for other cancers.
The S-488210/S-488211 vaccine is also an immunotherapy and it works in a similar way to durvalumab. The vaccine is an experimental drug. It isn’t used as a treatment for any cancer.
In this study you have durvalumab and the S-488210/S-488211 vaccine.
The aims of the study are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You can’t take part if any of the following apply. You:
You are also not able to donate blood while taking part in the study and for at least 3 months after the last dose of study treatment.
This is a phase 1/2 study. The team need 64 people to join.
Everyone has durvalumab and the S-488210/S-488211 vaccine. You have durvalumab as a drip into the vein. You have the S-488210/S-488211 vaccine as an injection under the skin.
You have treatment in cycles. Each is 4 weeks. You have up to 7 cycles of treatment as long as the treatment is helping and the side effects aren’t too bad.
Cycle 1
On the first day you have durvalumab by itself. On day 2 you have the vaccine by itself.
You then have the vaccine by itself once a week for the next 3 weeks.
Cycle 2
On the first day you have durvalumab and the vaccine.
You then have the vaccine once a week for the next 2 weeks.
Cycle 3
On the first day you have durvalumab and the vaccine.
You then have the vaccine by itself again at the start of the 2nd week.
Around 3 months after you start study treatment (around cycle 3) you have a cystoscopy to see how well the treatment is working. You continue to have the study treatment if the treatment is working as expected.
Cycles 4, 5 and 6
On the first day you have durvalumab and the vaccine.
You then have the vaccine by itself again at the start of the 2nd week
Cycle 7
You have durvalumab and the vaccine on the first day.
Samples for research
The study team take blood samples and urine samples during the study. Your doctor will tell you when they take these. Where possible they will take the blood samples at the same time you have blood taken for your routine tests.
You have a cystoscopy when you join the study. As part of your routine care after starting treatment you have a cystoscopy at:
At 6 months and 12 months you have a tissue sample (biopsy) taken. The study team will ask to use these tissue samples for research.
Quality of life
You fill in a questionnaire:
Your doctor will tell how often you fill the questionnaire in.
The questions ask about:
This is a quality of life questionnaire.
Diary
You have a diary to fill in at home. In this you record any side effects and any medications you take. You need to bring this diary with you whenever you go to the hospital.
Your doctor will tell what you need to record in the diary and how often you need to do so.
You see the doctor to have tests before taking part. These tests include:
You see the doctor at regular times during treatment and a month after finishing treatment. You then see them:
You have a CT urogram or MRI scan:
You have a cystoscopy every 3 months for a year after starting treatment.
The study 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 and the S-488210/S-488211 vaccine can affect the immune system. They 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. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. 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 S-488210/S-488211 vaccine is new and has not been tested in a study before. So we don’t know what the side effects of the vaccine are.
Other studies have used similar vaccines to S-488210/S-48211 and the side effects reported were quite minor.
You might have changes to the skin or irritation where you have the injection. You will have the injection in different areas of the body to help with this.
This is the first time that durvalumab and the S-488210/S-488211 vaccine have been used together. So we don’t know what the side effects might be when you have them together.
We have information about durvalumab and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Mark Linch
University College London (UCL)
CRUK & UCL Cancer Trials Centre
Shionogi & Co Ltd
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.