A trial of pembrolizumab in combination with other drugs for ovarian cancer (KEYNOTE-B96)

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

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at the combination of pembrolizumab and paclitaxel with or without bevacizumab. It is for women whose cancer has come back after having chemotherapy that included a platinum drug Open a glossary item .

The trial is for women who have:

These cancers are similar and the treatments are the same. In this summary when we use ovarian cancer we are referring to all 3 cancers.

More about this trial

The first treatment (first line treatment Open a glossary item ) doctors usually treat ovarian cancer with is a platinum drug such as carboplatin. You might have this by itself or with another chemotherapy drug such as paclitaxel.

However the cancer sometimes comes back within 6 months of having the platinum drug. This is platinum resistant ovarian cancer. When this happens you might have other drugs such as paclitaxel and bevacizumab.

Paclitaxel is a chemotherapy drug. It works by stopping cancer cells from dividing into 2 new cells. This blocks the growth of the cancer.

Bevacizumab is a targeted drug Open a glossary item . It works by stopping a protein that cancer cells need to grow new blood vessels. This means the cells aren’t able to get the food and oxygen they need to grow.

Researchers think that another targeted drug called pembrolizumab might help women with platinum resistant ovarian cancer.

Pembrolizumab is an immunotherapy Open a glossary item . It works by stimulating the immune system to recognise and kill cancer cells.

To find out if pembrolizumab can help, half the people in the trial have pembrolizumab and the other half have a dummy drug (placebo Open a glossary item ).

In this trial you have either:

pembrolizumab and paclitaxel with or without bevacizumab
dummy drug (placebo) and paclitaxel with or without bevacizumab

The aims of this trial are to find out:

whether adding pembrolizumab to paclitaxel with or without bevacizumab is better than not adding it
what the side effects are when pembrolizumab is added
how adding pembrolizumab 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 are female and all of the following apply. You:

have epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
have had 1 or 2 courses of treatment with at least 1 course including a platinum drug . Your doctor will know this.
have a scan that shows your cancer started to grow again within 6 months after having the last dose of the platinum drug
are able to have paclitaxel and bevacizumab
can do everything but might not be able to do heavy physical work (performance status 0 or 1)
are willing to use reliable contraception during treatment and for a period of time after if there is any chance you could become pregnant
have an area of cancer that the doctor can see on a scan
have a sample of cancer tissue (biopsy ) that the trial team can ask for a piece of. This could be an old sample or a recent one. If this isn’t available you must be willing to have a fresh sample taken.
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 a germ cell tumour, sex cord stromal tumour, border line tumour, mucinous , seromucinous that is mostly mucinous, undifferentiated carcinoma or a malignant Brenner’s tumour. Your doctor will know what type of cancer you have.
Your cancer got worse while having the platinum drug or within 28 days after finishing treatment that included the platinum drug.
Your cancer got worse while having paclitaxel once a week on its own.
You have had more than 2 courses of systemic treatment for ovarian cancer.
You have had systemic treatment within 4 weeks of being put into a trial treatment group (randomisation ). This includes an experimental drug or device in a clinical trial and any maintenance treatment including maintenance treatment with bevacizumab. If you are taking hormone therapy you can continue to take it until your randomisation.
You have ongoing side effects from earlier treatment. This is apart from certain ones which your doctor will know.
You had another cancer within the past 3 years that is continuing to grow or needs active treatment. This is apart from successfully treated non melanoma skin cancer and carcinoma in situ (CIS ). You cannot take part if you had CIS of the bladder.
You have cancer spread to the brain, spinal cord, tissues surrounding the brain or any combination of these. This is unless it has been treated, is stable and you haven’t been taking steroids within 2 weeks of starting trial treatment.

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

have radiotherapy within 2 weeks of starting the trial treatment
have ongoing complications from surgery or have not fully recovered
have had a growth factor such as G-CSF or GM-CSF within the 4 weeks before randomisation
have an immune system that isn’t working well. You are taking any medication such as steroids that damps down the immune system. This is apart from a small dose of steroids.
have an autoimmune disease that needed systemic treatment in the past 2 years. This is apart from certain autoimmune diseases that your doctor will know about.
have or had inflammation of the lungs not caused by an infection (pneumonitis ) or a disease affecting the lung tissue
have an active infection that needs systemic treatment. You have HIV, hepatitis B or active hepatitis C.
have had an organ transplant . You have had a stem cell or bone marrow transplant from a donor (allogeneic transplant ).
have any other medical condition, mental health problem or social situation that could affect you taking part

If you are to have bevacizumab
You cannot join this trial if any of the following also apply. You:

have high blood pressure that isn’t controlled
have certain bowel problems such as a bowel obstruction , an abnormal opening (fistula ) between the bowel and another area of the body or the outside of the body. There are other bowel problems that your doctor will know about.

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

are allergic or very sensitive to any of the drugs used, any of their ingredients or how they are made
have a live vaccine within 30 days of starting trial treatment
are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The team need 616 women worldwide to take part.

It is a double blind randomised trial. There are 2 treatment groups. Neither you nor your doctor chooses which group you are in. And neither will you nor your doctor know which group you are in.

During the trial your doctor will be able to find out which treatment group you are in if it becomes necessary.

The 2 treatment groups are:

pembrolizumab and paclitaxel with or without bevacizumab
dummy drug (placebo) and paclitaxel with or without bevacizumab

18961-randomisation.png

You doctor will talk to you about whether you are to have bevacizumab or not.

During the trial your doctor might want to give you docetaxel instead of paclitaxel. Docetaxel is similar to paclitaxel and doctors use it to treat ovarian cancer. Your doctor will talk to you about this before they swap them.

You have all the treatments through a drip into a vein.

You have pembrolizumab and the dummy drug once every 6 weeks. This is a cycle of treatment Open a glossary item . You have a maximum of 18 cycles (2 years).

You have paclitaxel once a week. If you are having bevacizumab you have it every 2 weeks.

If you have docetaxel instead of paclitaxel you it every 3 weeks.

You continue to have treatment as long as it is helping and the side effects aren’t too bad.

You might be able to continue treatment if your cancer gets worse while having treatment. Your doctor will talk to you about this if it happens.

After completing treatment if your cancer gets worse you might be able to have a further 9 cycles of pembrolizumab. This is only if you had pembrolizumab. Your doctor will talk to you about this if this is the case for you.

Quality of life
You fill in questionnaires:

before starting treatment
while you are having treatment
at the end of treatment

The questions ask about:

your general health and wellbeing
what you are able to do
any side effects

These are quality of life questionnaires.

Samples for research
You give blood samples and tissue samples as part of the trial. Where possible the team take these samples when you have bloods or tissue taken as part of your routine care.

Researchers will use these samples to look:

at the genes
for substances called biomarkers

This can help them find out:

why treatment might work better for some people and not others
how well treatment works
how they affect the cancer

Hospital visits

You see the doctor before taking part to have some tests. These include:

a physical examination
blood tests
urine test
heart trace (ECG)
CT scan or MRI scan
bone scan, an x-ray or both

During treatment you see the doctor at regular times. This is:

to see how you are
for blood and urine samples
for scans

A month after treatment you see the doctor and then every 9 weeks or 12 weeks. Your doctor will tell you which one it is.

You have a scan every 9 weeks for a year and then every 12 weeks while you are in the trial.

You stay in the trial until your cancer starts to get worse or you start another treatment.

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 Open a glossary item . This may cause inflammation and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects.

These side effects could happen during treatment or 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 most common side effects of pembrolizumab are:

itching, skin rash and loss of skin colour
diarrhoea
cough
joint pain, back pain, tummy (abdominal) pain
high temperature (fever)
your thyroid not making enough hormones. This can cause tiredness, feeling cold, weight gain and constipation.
a low level of salt in the blood. This can cause tiredness, confusion, headaches, muscle cramps and feeling sick.

We have more information about pembrolizumab. We have information about the side effects of:

Your doctor will talk to you about the side effects of the treatments and answer any questions you might have before you decide to take part in the trial.