A trial looking at durvalumab and BCG for people with bladder cancer (POTOMAC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bladder cancer

Transitional cell cancer

Status:

Closed

Phase:

Phase 3

This trial is for people with early stage bladder cancer. Early stage bladder cancer means that the cancer is only in the lining of the bladder. It has not grown into the deeper layers of the bladder wall.

It is for people who are going to have BCG into the bladder for the first time.

More about this trial

BCG into the bladder is a common treatment for people with early bladder cancer. It contains a bacteria which has been weakened so that it can be used as a cancer treatment.

BCG works well for most people. But in some people, the treatment doesn’t work and the cancer comes back in a short period of time.

Durvalumab is a targeted cancer drug called a monoclonal antibody. It seeks out cancer cells by looking for a particular protein and attaching to it.

Researchers think that durvalumab helps the immune system find and kill cancer cells. You have durvalumab as a drip into your bloodstream.

Everyone taking part in this trial has 1 of the following:

durvalumab and BCG
BCG

The main aim of this trial is to find out how well durvalumab and BCG work as a treatment for early bladder cancer.

Who can enter

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.

Who can take part

You may be able to join this trial if all of the following apply:

you have an early (non muscle invasive) transitional cell carcinoma of the bladder (early bladder cancer)
you have had an operation to remove all of your cancer in the last 4 months (transurethral resection of the bladder tumour or TURBT)
you are well enough to carry out your normal activities apart from heavy physical work (performance status of 0 or 1)
you have a suitable sample of cancer available that is less than 3 years old (or you are willing to have a new sample taken)
you weigh more than 30 kg (4 stone 10lb)
doctors think that BCG into the bladder is a suitable treatment for you
you have satisfactory blood tests results
your heart is working well
you are at least 18 years old
you are willing to use reliable contraception during treatment and for 3 months afterwards if there is any possibility that you or your partner could become pregnant

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

you have a T2, T3, T4 or stage 4 bladder cancer
have had BCG into the bladder, unless it was more than 3 years ago
your cancer has spread to the blood vessels or the lymph vessels
you have had radiotherapy to the bladder
you have had durvalumab or any other similar drug
you have had treatment with a cancer vaccine
doctors think you need to have an operation to remove the bladder (cystectomy)
you can’t have BCG into the bladder for any reason
as well as bladder cancer, you also have cancer of your urethra, ureter or renal pelvis (transitional cell carcinoma of the urothelium)
you are taking part in an interventional clinical trial, or you have had an experimental treatment (drug or device) in the past 28 days. Observational studies are allowed
you have taken part in a clinical trial where durvalumab was a possible treatment, even if you didn’t join the durvalumab treatment group
you are having cancer treatment such as chemotherapy, hormone therapy or targeted drugs
you are taking drugs that stimulate the immune system such as G-CSF
you have had a donor transplant (allogeneic transplant)
have had another cancer in the past 5 years apart from cancers that haven’t spread (carcinoma in situ) or a non melanoma skin cancer that has been successfully treated

Medical conditions

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

have had a major surgery in the past month
have an autoimmune disease apart from a skin condition called vitiligo, alopecia or hypothyroidism that has been stable
have an active infection
have had a bladder infection or a urinary tract infection in the last 2 weeks
have taken antibiotics that reached your whole body (systemic) in the past 2 weeks
have heart problems such as congestive heart disease, high blood pressure or unstable angina
have problems with your digestive system that are causing diarrhoea
have had or have active tuberculosis
have HIV
have hepatitis B or hepatitis C
have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks unless it was a very small dose, an inhaler or a cream
have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other

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

are pregnant or breastfeeding
have had a live vaccine in the past 30 days
are sensitive to durvalumab, BCG or anything they contain
are involved in the planning or running of this trial

Trial design

This is an international phase 3 trial. Researchers hope that around 52 people from the UK will agree to take part.

It is a randomised trial. The people taking part are put into 1 of the following treatments by computer:

durvalumab and BCG (induction and maintenance)
durvalumab and BCG (induction only)
BCG (induction and maintenance)

Neither you nor your doctor will be able to decide which group you join.

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Durvalumab and BCG (induction and maintenance)

You have durvalumab as a drip into a vein (intravenously) every 4 weeks, for a year.

You also have BCG as a treatment into your bladder (intravesical). You have it:

once a week for 6 weeks
then once a week for 3 weeks at set months during this trial. Your doctor will give you more information about how often you have it

Durvalumab and BCG (induction only)

You have durvalumab as a drip into your vein every 4 weeks, for a year. And BCG as a treatment into your bladder once a week, for 6 weeks.

BCG (induction and maintenance)

You have BCG as a treatment into your bladder. You have it:

once a week for 6 weeks
then once a week for 3 weeks at set months during this trial. Your doctor will give you more information about how often you have this

Tissue sample

The trial team ask to use a tissue sample of your cancer taken when you had an operation or a biopsy. You need to have a new sample taken if there isn’t a suitable sample available.

The trial doctors may also ask you to have a new sample taken if your cancer comes back.

Blood tests

You have extra blood tests as part of this trial. You have them before the start of treatment and then:

at set times during this trial
at 4 weeks, 8 weeks and 12 weeks after you finish treatment

Researchers want to look for biomarkers and find out what happens to durvalumab in your body.

Quality of life questionnaire

Everybody taking part completes quality of life questionnaires before the start of treatment and then every 4 to 8 weeks.

This continues for as long as you are having treatment or tests that are part of this trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

a physical examination
heart trace (ECG)
blood tests
urine test
a CT scan
a test to look at the inside of your bladder (cystoscopy)

During treatment, you see the trial doctor regularly. How often you see them depends on the treatment you have. You have blood tests and a physical examination every time you see them.

You have a cystoscopy every 3 months, for 3 years. You then have it every 6 months. This continues for as long as your cancer stays the same and doesn’t come back.

When you finish treatment, you see the trial team after:

4 weeks
8 weeks
3 months

You then see or speak with the trial team every 6 months for up to five years.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment.

The most common side effects of durvalumab are: