
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at pembrolizumab for cervical cancer that has spread into the surrounding tissue (locally advanced) and has a high risk of coming back.
Chemotherapy with radiotherapy (chemoradiotherapy) is one of the standard treatments for locally advanced cervical cancer.
Pembrolizumab is an . It works by helping the
kill cancer cells.
We know from research that adding pembrolizumab to chemoradiotherapy can help people with other types of cancers. Researchers think that it could also help people with cervical cancer.
In this trial researchers will compare having chemoradiotherapy with pembrolizumab to chemoradiotherapy with a dummy drug ().
The aims of the trial are to find out how:
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:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The trial team need about 980 women worldwide to take part with 6 people from the UK.
This is a randomised double blind trial. You go into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor will know which treatment you have. During the trial your doctor will be able to find out which treatment you are having if they need to.
The groups are:
Chemoradiotherapy
Chemoradiotherapy is having chemotherapy at the same time as having radiotherapy.
The chemotherapy you have is cisplatin. You have cisplatin as a drip into a vein. You have cisplatin once a week for 5 weeks. You might have another week of cisplatin. Your doctor will tell you if you are going to have this.
You have external radiotherapy once a day Monday to Friday for 5 weeks. Before starting radiotherapy you have a planning appointment. This is so the doctor and the radiographer can work out where to give the radiotherapy and how much to give.
After external radiotherapy you have internal radiotherapy (brachytherapy). You can have brachytherapy in the hospital as an inpatient. Or you might have it as an outpatient in the radiotherapy department. Your doctor will talk to you about this. And about how many treatments you have.
For brachytherapy you have a radioactive applicator put into your vagina and cervix. This delivers radiotherapy to the cancer and very little to the surrounding tissue. When the applicator is in you need to lie flat on your back and still.
Pembrolizumab or the dummy drug
You have pembrolizumab or the dummy drug the same way. You have it as a drip into a vein. During chemoradiotherapy you have it once every 3 weeks. Each 3 week period is a . You have 5 cycles of treatment.
After chemoradiotherapy each cycle of treatment is once every 6 weeks. You have 15 cycles of treatment.
Quality of life
You fill in a few questionnaires at the start of treatment and then:
The questions ask about:
These are quality of life questionnaires.
Research samples
You give blood samples during treatment.
The trial team will also ask for a piece of the sample tissue (biopsy) from a previous sample. If this is not available you must be willing to have a fresh biopsy taken.
Researchers will use these samples to:
You see the doctor for tests before taking part. These tests include:
You see the doctor regularly during treatment to see how you are and for blood tests.
3 months after finishing chemoradiotherapy you have a:
After treatment you see the doctor every 3 months for 2 years and then:
You have a CT scan and an MRI scan every time you see the doctor. You might have an extra scan if one of the scans shows your cancer might be getting worse. If this happens your doctor will talk to you about whether you should continue having treatment or not.
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. This 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 tell your 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:
We have more information about pembrolizumab.
We have information about the side effects of:
Your doctor or a member of the trial team will talk to you about the possible side effects of all the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Susan Lalondrelle
Merck, Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”