
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for women with ovarian cancer that has come back (recurrent cancer) after having surgery and platinum chemotherapy. Platinum chemotherapy includes the drugs cisplatin, carboplatin and oxaliplatin.
It is for women who have:
These cancers are treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all three.
Surgery followed by chemotherapy is used to treat ovarian cancer. Often a platinum chemotherapy such as carboplatin is used.
But sometimes the cancer can come back after chemotherapy. This is called recurrent cancer.
Doctors can treat recurrent ovarian cancer with more chemotherapy but they are looking for new treatments to help women in this situation.
In this trial, they are looking at a drug called pembrolizumab (also called Keytruda).
Pembrolizumab is already used to treat other types of cancer. It is a type of biological therapy called a monoclonal antibody.
Researchers think it may help your immune system attack the cancer and stop it from growing.
The aims of this trial are to:
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.
You may be able to join this trial if all of the following apply:
As well as the above, 1 of the following must apply:
You cannot join this trial if any of these apply:
This is an international phase 2 trial. The researchers need about 325 people to take part worldwide and hope that around 16 people from the UK will take part.
Everyone taking part has pembrolizumab. You have it as a drip into a vein every 3 weeks. It takes about 30 minutes.
You continue to have pembrolizumab for as long as your cancer doesn’t get worse and the side effects aren’t too bad. You can have it up to 35 times (over about 2 years).
If your cancer goes away and then comes back again, you may be able to have an extra 17 treatments. Your doctor can tell you more about this.
Blood tests
You have some extra blood tests as part of this trial. The researchers want to find out what happens to pembrolizumab in the body.
They will also look for substances called to see why treatments work better for some people than others.
Researchers will ask to store your blood samples for 15 years and use them in future studies.
You do not have to agree to have your blood stored if you don’t want to. You can still take part.
Tissue samples
You also need to give a tissue sample (biopsy) of your cancer before you start treatment. This is to check if there is a marker on your cancer called PD-L1.
Researchers will ask to use a tissue sample of your cancer taken either when you were diagnosed or during other treatments. If there is not a suitable sample available the researchers will ask you to have a biopsy.
They will also ask to store your tissue samples and use them in future studies. Again you do not need to agree to this research if you don’t want to.
You see a doctor and have some tests before taking part. These tests include:
You see the doctor for blood tests and a physical examination every 3 weeks.
You have a CT or an MRI scan every 9 weeks while you are having treatment. After 54 weeks you have a CT or an MRI scan every 12 weeks.
This will continue for as long as your cancer stays the same and does not get worse. If your cancer gets worse you stop having pembrolizumab.
When you finish your treatment you see the trial team:
After 12 months the trial team will phone you every 12 weeks to see how you are.
The trial team monitor you during the time you have treatment and you will be given 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 trial.
The most common side effects of pembrolizumab are:
We have more information about pembrolizumab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Jonathan Ledermann
Merck, Sharp & Dohme
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”