A trial of BMS-986205, nivolumab and chemotherapy for bladder cancer (CA017078)

Cancer type:

Bladder cancer

Status:

Open

Phase:

Phase 3

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:

  • whose cancer has spread into or through the muscle layer of the bladder. This is called invasive bladder cancer.
  • who are going to have surgery to remove the bladder

More about this trial

You might have chemotherapy before surgery for invasive bladder cancer. This is a standard treatment Open a glossary item 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 immune system Open a glossary item 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:

  • chemotherapy on its own (standard treatment)
  • chemotherapy, nivolumab and a dummy drug (placebo Open a glossary item)
  • chemotherapy, nivolumab and BMS-986205

The main aims of the trial are to find out:

  • which treatment works best
  • more about the side effects
  • 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 cancer that has grown into the muscle wall in the bladder (stage T2-T4a) but it hasn’t spread to the lymph nodes Open a glossary item. You might be able to take part if you have tiny areas of cancer in the nodes that are smaller than 10mm. 
  • have cancer that hasn’t spread to distant parts of the body 
  • are suitable to have surgery to remove the bladder (radical cystectomy) and agree to have it 
  • are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
  • have a tissue sample that shows if your cancer has the PD-L1 protein or not 
  • are willing to use reliable contraception if there is any chance you or your partner could become pregnant
  • have satisfactory blood test results 
  • 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 treatment for bladder cancer in the past such as chemotherapy, immunotherapy, radiotherapy or surgery for bladder cancer. This doesn’t include surgery to treat early bladder cancer (a TURBT) or having tissue samples taken. 
  • had had an immunotherapy Open a glossary item or a similar drug in the past 
  • have cancer that has spread to the lymph nodes unless it measures less than 10mm on a scan  
  • have cancer that has spread to distant parts of the body 
  • can’t have cisplatin because you have moderate to severe tingling or numbness in your hands or feet, you have hearing loss or your kidneys aren’t working well  
  • have had another cancer in the last 3 years. This is apart from successfully treated non melanoma skin cancer Open a glossary item, carcinoma in situ (CIS Open a glossary item) of the cervix, prostate, or breast or early bladder cancer. 
  • have had an experimental treatment within 4 weeks of starting trial treatment 

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

  • have an active autoimmune disease Open a glossary item that needed treatment in the last 2 years apart from certain ones. The trial team check this before you can join the trial. 
  • have problems with your digestive system Open a glossary item  that means you can’t absorb medication you take by mouth 
  • have a problem with your immune system Open a glossary item or are taking medication to damp it down unless it is a low dose
  • have a problem with how your adrenal glands Open a glossary item work and they don’t make enough hormones Open a glossary item 
  • have a serious heart problem such as a heart attack in the last 6 months or another heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. 
  • have had a stroke in the last 6 months 
  • bleed or bruise easily or you have problems with how your blood clots. You may join the trial if you are taking medication to thin your blood as long as you are on a stable dose.  
  • have a condition that causes you to have low levels of oxygen in your blood (cytochrome b5 reductase deficiency) or a close family member has this condition 
  • have a condition called methemoglobinemia
  • have a condition called G6PD deficiency or disorder in which red blood cells are destroyed faster than they can be made
  • have a condition called serotonin syndrome
  • have a lung condition called interstitial lung disease or inflammation of the lungs or you had this in the past and needed to have steroids to treat it. This doesn’t include pneumonitis caused by radiotherapy.
  • have had major surgery within 14 days of being put into a treatment group or you need to have a major operation
  • have HIV, AIDS, an active hepatitis B or hepatitis C infection or any other 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 Open a glossary item within 30 days of starting trial treatment. Please note that the current approved COVID-19 vaccines are allowed as they aren’t a live. 
  • have had herbal supplements or traditional Chinese medicines to treat your cancer within 2 weeks of starting trial treatment
  • are allergic to the trial drugs or anything they contain 
  • are pregnant or breastfeeding

Trial design

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: 

  • chemotherapy before surgery and no treatment after surgery. This is the standard treatment (group A).
  • chemotherapy, nivolumab and the dummy BMS-986205 drug before surgery. You also have nivolumab and the dummy drug after surgery (group B).
  • chemotherapy, nivolumab and BMS-986205 before surgery. You also have nivolumab and BMS-986205 after surgery (group C).

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 treatment in cycles Open a glossary item. 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:

  • nivolumab as a drip into a vein once every 3 weeks
  • BMS-986205 or dummy drug tablets. You take them once a day, every day. 

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:

  • group A have no more treatment
  • group B have nivolumab and the dummy drug
  • group C have nivolumab and BMS-986205

This treatment period takes about 9 months. Those having treatment start it within 4 months of having surgery. 

People in groups B and C:

  • have nivolumab once every 4 weeks
  • take BMS-986205 or the dummy drug once a day, every day.

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:

  • look at genes Open a glossary item on the cancer cells to understand more about bladder cancer 
  • see what happens to nivolumab and BMS-986205 in the body 
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

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

  • 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.

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.

Hospital visits

You see the doctor to have some tests when you agree to take part. These tests include:

  • a physical examination Open a glossary item 
  • blood tests
  • urine test
  • heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

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:

  • 1 month
  • 3 months 

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.

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. 

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:

  • your skin tuning blue (cyanosis)
  • weakness
  • shortness of breath
  • headache and confusion
  • changes to the heart rhythm 

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 pneumonitis Open a glossary item. You should contact your trial doctor or nurse at once if you develop any of the following:

  • new or increased shortness of breath
  • new or increased chest pain
  • new or increased pain or difficulty breathing
  • new or increased cough or any big change in the type of cough. For example any new or increased mucous or you are coughing up blood. 
  • a change in the amount of oxygen you need
  • high temperatures or extreme tiredness 
  • any other symptoms that occur at the same time as any changes to your breathing or other lung symptoms

 

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:

Location

Manchester
Northwood
Preston
Southampton
Swansea

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Thomas Waddle

Supported by

Bristol-Myers Squibb
National Institute for Health Research (NIHR)

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17483

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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