A trial of pembrolizumab for cancer of unknown primary (CUPem)

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

Cancer type:

Cancer of unknown primary (CUP)

Secondary cancers

Status:

Closed

Phase:

Phase 2

This trial is looking at pembrolizumab for people who have cancer of unknown primary (CUP).

Cancer of unknown primary means that cancer spread has been found in your body (secondary cancer). But your doctors can't find where the cancer started (the primary cancer).

More about this trial

Chemotherapy is one of the main treatments for cancer of unknown primary (CUP). But sometimes it doesn’t work or the cancer comes back. So doctors are looking for ways to improve treatment. In this trial they are looking at a drug called pembrolizumab.

Pembrolizumab is a type of immunotherapy. It stimulates the body's immune system Open a glossary item to fight cancer cells.

Some people in this trial have already had chemotherapy for CUP. And some haven’t and are having pembrolizumab as their first treatment.

The main aims of the trial are to:

find out if pembrolizumab works better than chemotherapy
learn more about the side effects
see how treatment affects quality of life

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 if all of the following apply. You:

have cancer spread in your body but the doctors don’t know where the cancer started (cancer of unknown primary or CUP)
have had chemotherapy for CUP but it didn’t work, your cancer came back or you had to stop treatment because of bad side effects, or you haven’t had chemotherapy
have cancer that your doctor can measure on a scan
have a sample of tissue (biopsy ) available for the trial team to test
are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
have satisfactory blood test results
are willing to use reliable contraception during treatment and for 120 days afterwards if you or your partner could become pregnant
are at least 18 years old

Who can’t take part
You cannot join this trial if any of these apply.

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

have cancer spread in your brain or spinal cord. You might be able to take part if the cancer has been stable for 4 weeks and you haven’t had steroids in the 7 days before starting trial treatment.
have cancer spread in the tissues that surround the brain (carcinomatous meningitis)
have taken part in a trial that used an experimental drug or device within 4 weeks of starting trial treatment
have had a monoclonal antibody or immunotherapy within 4 weeks of starting trial treatment or you have side effects from these treatments unless they are mild
have had chemotherapy, targeted drugs or radiotherapy within 2 weeks of starting trial treatment or you have side effects that aren’t better unless they are mild
have had treatment with pembrolizumab or a similar drug in the past
have another cancer that is getting worse or needs treatment apart from non melanoma skin cancer or carcinoma in situ (CIS ) of the cervix that has been successfully treated

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

have an active autoimmune disease that needed treatment in the last 2 years apart from diabetes or hormone problems that are controlled by medication
have a problem with your immune system or you are having steroids or any other medication that damps down the immune system within 7 days of starting trial treatment
have or have had tuberculosis (TB)
have or have had inflammation of the lung caused by treatment (pneumonitis) and you needed treatment with steroids
have an active infection that needs treatment
have HIV
have an active hepatitis B or hepatitis C infection
have any other medical condition, mental health problem or problem with drugs or alcohol that the trial team think would affect you taking part

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

are sensitive to pembrolizumab or anything it contains
are pregnant or breastfeeding
are planning a pregnancy or to father a child during the trial
have had a live vaccine within 30 days of starting trial treatment

Trial design

This is a phase 2 trial. It is taking place in the UK. The researchers need 77 people to join.

Everyone has pembrolizumab. You have treatment as a drip into a vein. You have treatment once every 3 weeks. The treatment takes 30 minutes each time. But you will be at the hospital for longer than this.

You have treatment for as long as it is working and the side effects aren’t too bad.

You stop treatment if your cancer gets worse. The trial doctor will talk to you about other treatment options.

Samples for research
The researchers ask for a sample of your cancer (biopsy) Open a glossary item that doctors took when you were diagnosed.

They also ask for 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
look for biomarkers to predict who will benefit from treatment

Quality of life
The study team will ask you to fill out a questionnaire before you start treatment and 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.

Hospital visits

You see a doctor and have some tests before you can take part in the trial. These include:

physical examination
blood tests
urine tests
heart trace (ECG)
CT scan

You have your treatment at the hospital in the outpatient department. You see the trial doctor once every 3 weeks for a check up and blood tests.

You have a CT scan every 3 months until your cancer gets worse.

If you stop treatment but your cancer isn’t worse, you continue to have a CT scan every 2 months.

When you stop treatment you see the trial team 1 month later for a check up.

You continue to see or speak with the trial team every 4 months. This is to check how you are getting on.

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.

Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body which 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, you should tell the doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

The common side effects of pembrolizumab are:

itchy skin or skin rash
diarrhoea
cough
joint pain
fever
back pain
pain in your belly
loss of skin colour
low levels of thyroid hormone that may cause you to feel tired, gain weight, feel cold, or be constipated
low levels of salt in the blood that may cause you to feel tired, feel confused, have a headache, have muscle cramps or feel sick