
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at adding BMS-986205 and nivolumab to chemotherapy before surgery for bladder cancer. It is also looking at having BMS-986205 and nivolumab after surgery.
It is for people:
You might have chemotherapy before surgery for invasive bladder cancer. This is a option and might include 2 drugs called gemcitabine and cisplatin.
Doctors are looking at ways to improve treatment. In this trial they are looking at adding 2 drugs called BMS-986205 and nivolumab.
BMS-986205 and nivolumab are both immunotherapies. They work in different ways to help your find and kill cancer cells. Nivolumab is already a treatment for some other types of cancer. BMS-986205 is a new drug.
Doctors aren’t sure how well these treatments will work for bladder cancer. So they are running this trial to find out more.
In this trial you have 1 of the following:
The main aims of the trial are to find out:
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:
Who can’t 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:
This is a phase 3 trial. The team need about 1,200 people to take part including 36 from the UK.
There are 3 treatment groups.
This is a randomised trial. A computer puts you into a treatment group. You have 1 of the following:
Neither you nor your doctor can decide which group you are in. And neither you nor your doctor will know if you are having BMS-986205 or the dummy drug. They can find this out if necessary.
Treatment before surgery
This treatment period lasts for 3 months.
Everyone has chemotherapy before surgery. You have . Each 3 week period is a cycle of treatment. You have gemcitabine and cisplatin once every 3 weeks
This takes about 2 to 3 hours each time. You have up to 4 cycles of treatment.
People in group B and C also have immunotherapy. You have:
Surgery
You have surgery to remove your bladder as planned. You have this surgery within 6 weeks of the last dose of trial treatment. Your surgeon or doctor can tell you more about the surgery and what it involves. You can ask them any questions you may have.
Some people might not be suitable to have surgery. Your doctor will explain why if this applies to you and what your treatment options are.
Treatment after surgery
Some people have treatment after surgery and some don’t. This depends on the group you are in:
This treatment period takes about 9 months. Those having treatment start it within 4 months of having surgery.
People in groups B and C:
You have up to 9 cycles of treatment.
Samples for research
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:
Quality of life
The trial team ask you to fill out questionnaires:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Medication diary
You fill in a diary if you are taking BMS-986205 or the dummy drug. You fill it in when you take your tablets and how many you took.
Please note, you should not have grapefruit, grapefruit juice, or Seville oranges while on trial treatment. It can interfere with the way that BMS-986205 works.
You see the doctor to have some tests when you agree to take part. These tests include:
You have chemotherapy and nivolumab on the day ward.
You see the doctor regularly during treatment to see how you are and for blood tests.
You have another CT or MRI scan after surgery if necessary. You then have a scan every few months. The team can tell you exactly how often you have them.
Follow up
Those in group A start their follow up after surgery.
Those in groups B and C start their follow when you stop treatment.
Everyone sees the trial doctor for a check up at:
You then see the trial team every 3 months for a check up. Or they might call you to see how you are getting on.
Some people might not have surgery to remove their bladder. Your doctor can tell you more if this applies to you. They can also tell you how often you have follow up appointments.
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.
BMS-986205 and nivolumab 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. 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. |
BMS-986205 is a new drug so there might be some side effects we don’t know about yet. The most common side effects we know about so far include:
BMS-986205 may cause changes in your red blood cells. This can cause a condition called methemoglobinemia. This reduces the ability of your blood to carry oxygen. Symptoms include:
The trial doctors keep an eye on your oxygen levels and will treat any problems straight away.
The most common side effects of nivolumab are:
Having nivolumab and BMS-986205 together might cause you to develop inflammation of the lungs. This is called
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The trial team will do some tests to find out why you are having these symptoms.
The trial doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask any questions you may have.
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Thomas Waddle
Bristol-Myers Squibb
National Institute for Health Research (NIHR)
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”