A trial of pembrolizumab and olaparib for advanced pancreatic cancer (PemOla)
Cancer type:
Status:
Phase:
This trial is looking at treating pancreatic cancer that has spread to another part of the body with pembrolizumab and olaparib.
It is for people who:
- can’t have surgery to remove the cancer
- have a lot of gene changes (
mutations ) in the pancreatic cancer cells
More about this trial
Cancer that has spread to another part of the body is advanced or metastatic cancer. Doctors are trying to improve treatment for people whose pancreatic cancer has spread.
Some people with pancreatic cancer have very high levels of gene changes (
We know from research that immunotherapy drugs might help people whose cancer has these gene changes.
Pembrolizumab is an immunotherapy. It works by helping the
Olaparib is a type of targeted cancer drug called a
The main aims of the trial are to find out:
- how well the combination of pembrolizumab and olaparib works for pancreatic cancer that has spread
- more about the side effects of this treatment combination
- 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 the most common type of pancreatic cancer called ductal adenocarcinoma of the pancreas that has spread to other parts of the body
- have already had tests that confirm you have high levels of gene changes in the cancer cells or you have cancer that has DNA changes called
microsatellite instability high ormismatch repair deficiency . Your doctor will know this. - have had no more than one
systemic treatment for pancreatic cancer that couldn’t be removed with surgery. This was for cancer that may have spread to the large blood vessels near the pancreas, or to a severallymph nodes (stage 3 cancer). Or for cancer that had spread to other parts of the body (stage 4 cancer). Your doctor will know this. - have cancer that your doctor can see on a scan that hasn’t been treated with
radiotherapy - are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- 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 pancreatic cancer that can be removed with surgery or you have cancer that has spread only into the surrounding tissues but no further
- have cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you have had treatment, the cancer is stable and you have stopped taking steroids.
- have had more than one systemic treatment for pancreatic cancer that has spread to other parts of the body
- have had
checkpoint inhibitors ,immunotherapy or a drug similar to olaparib in the past - have another cancer that is getting worse or needed treatment within the last 3 years. You can take part if you have
non melanoma skin cancer orcarcinoma in situ that has been successfully treated. You can’t take part if you have early bladder cancer. - have had another cancer in the last 2 years and you have not had treatment with the aim to cure
- have had radiotherapy within 2 weeks of starting trial treatment. You can’t take part if you still have side effects from radiotherapy or are taking
steroids . You can take part if you have radiotherapy to help with symptoms within 1 week. - are having treatment to help your body make blood cells. This includes
G-CSF ,GM-CSF orerythropoietin . And you have this within 28 days of starting trial treatment.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had treatment that damps down the
immune system . This includes steroids unless it is a low dose. - have
myelodysplastic syndrome (MDS) , acute myeloid leukaemia (AML ) or your doctor suspects might have either of these - have certain
lung problems . Your doctor will know what these are. - have had a heart attack in the last 2 months or a significant
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 2 months - have HIV, a hepatitis B or hepatitis C infection or any other severe infection that needs treatment
- have
liver problems - have an
autoimmune condition that needs treatment apart from certain ones. Your doctor will know about this. - can’t swallow tablets or absorb medication
- take medication that affects substances in the body called
CYP enzymes - are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of being put in a treatment group for this trial.
- have had a transplant with someone else’s cells (an
allogeneic transplant or anorgan transplant ) - have moderate side effects from past cancer treatments that aren’t getting better. This does not apply to hair loss.
- have another medical condition or mental health condition that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have severe allergies or are
sensitive to drugs - have had a severe allergic reaction to pembrolizumab or anything it contains
- have had a
live vaccine within 30 days of the start of treatment. Please note that the approved COVID-19 vaccines are allowed as they aren’t live vaccines. - are pregnant or breastfeeding or planning to become pregnant
Trial design
This phase 2 trial is taking place in the UK. The team need to find 20 people to take part.
Everyone has pembrolizumab and olaparib.
You have pembrolizumab as a drip into a vein once every 3 weeks. This takes about 30 minutes each time.
Olaparib is a tablet. You take them twice a day, every day. The team give you a diary to record when you take your tablets.
You start taking olaparib on the same day as your first treatment with pembrolizumab.
You have treatment for up to 2 years. This is for as long as it is working and the side effects aren’t too bad. You stop treatment if the cancer gets worse. Your doctor will talk to you about other treatment options.
Samples for research
The researchers will ask to look at tissue samples from previous
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about pancreatic cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - look for
circulating tumour DNA
The team will also ask you to give some urine and poo samples during the trial. They plan to use these to see what happens to treatment in the body.
Quality of life
The trial team ask you to fill out 2 questionnaires:
- before you start treatment
- at set times during and after treatment
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor and have tests before you can take part. These include:
You have pembrolizumab at the hospital in the outpatient department. You shouldn’t need to stay overnight. During treatment you see the doctor regularly. This is for blood tests and to see how you are.
Trial scans
You have a CT scan every:
- 9 weeks for 6 months and then
- every 12 weeks after that
You stop having the trial scans if the cancer gets worse.
Follow up
You see the doctor 1 month later if you stop treatment because the cancer gets worse.
The team will also ask you to complete a
They may check your medical notes to see how you are.
If you stop treatment but your cancer hasn’t got worse, you see the trial team:
- every 9 weeks for about 6 months and then
- every 12 weeks until your cancer gets worse
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 and olaparib is a new combination of treatment for pancreatic cancer. So there may be side effects we don’t know about yet.
Pembrolizumab can affect the 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. |
The most common side effects of pembrolizumab are:
- a drop in the number of red blood cells (
anaemia ) causing tiredness and breathlessness - feeling or being sick
- constipation or diarrhoea
- loss of appetite
- itchy skin or skin rash or patches of paler skin
- inflammation of the intestines
- headache
- shortness of breath or cough
- pain that affects the muscles, joints and bones
- tiredness (fatigue)
- low levels of
thyroid . You may feel tired, gain weight, feel cold, or have constipation. - fluid build up in the body
- high temperatures (fever)
The most common side effects of olaparib are:
- a drop in the number of blood cells causing an increased risk of infection, bleeding or bruising, tiredness and shortness of breath
- feeling or being sick
- diarrhoea
- shortness of breath
- indigestion or tummy pain
- changes to taste
- loss of appetite
- cough
- headache
- feeling dizzy
- tiredness
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.
Please note, you should avoid grapefruit, grapefruit juice, Seville orange juice, and St. John’s Wort while you are having pembrolizumab or olaparib.
We have more information about:
Location
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.
Chief Investigator
Dr Pippa Corrie
Supported by
Cambridge University Hospitals NHS Foundation Trust
National Institute of Health Research (NIHR)
Merck Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040