
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at a drug called pembrolizumab in combination with other drugs in prostate cancer.
It is for people with metastatic castration resistant prostate cancer (mCRPC). This means that the cancer:
Advanced prostate cancer is when the cancer has spread from the prostate to another part of the body (metastatic prostate cancer). A common treatment for advanced prostate cancer is hormone therapy. This can work well for a period of time, but the cancer can start to grow again.
Doctors are working on new treatments for when other treatments have stopped working.
Pembrolizumab (Keytruda) is a type of targeted drug called a . It targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the immune system cells to find and kill cancer cells.
The trial team are looking at giving pembrolizumab with other cancer drugs such as:
The aims of the trial are to:
Please note there are several treatment groups so the entry conditions for this trial are complex. Each group has specific entry conditions and we haven’t listed them all. Some groups are closed now.
The trial team will check if you are suitable to join the trial and which group you might join. They can tell you more about this.
Your doctor decides which group is best for you. To help them decide, they look at:
The following bullet points are a summary of the main 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:
As well as the above there are specific entry conditions and exclusion criteria for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial.
This is an international phase 1/2 trial. The trial team need around 1,000 people worldwide to join including 32 from the UK.
Because the trial team are looking at different combinations of drugs with pembrolizumab, everyone is put into one of 9 groups. And each group has a different drug combination.
Please note that groups A to D are closed to further recruitment. Groups E, F,G,H and I may be open for people to join. You can talk to the trial doctor about this.
Group E
This group is for people with adenocarcinoma. You have pembrolizumab and lenvatinib. Lenvatinib is a type of targeted cancer drug called a cancer growth blocker.
You have pembrolizumab as a drip into a vein. You have lenvatinib as capsules.
Group F
This group is for people with neuroendocrine cancer that has developed after previous treatment. This is treatment emergent neuroendocrine cancer. You have pembrolizumab and lenvatinib. Lenvatinib is a type of targeted cancer drug called a cancer growth blocker.
You have pembrolizumab as a drip into a vein. You have lenvatinib as capsules.
Group G
This group is for people with adenocarcinoma. You have MK-7684A. This is a mixture of an immunotherapy drug called vibostolimab (MK-7684) and pembrolizumab. Vibostolimab is a type of monoclonal antibody.
You have MK-7684A as a drip into a vein.
Group H
This group is for people with neuroendocrine cancer that has developed after previous treatment. This is treatment emergent neuroendocrine cancer. You have MK-7684A. This is a mixture of an immunotherapy drug called vibostolimab and pembrolizumab. Vibostolimab is a type of monoclonal antibody.
You have MK-7684A as a drip into a vein.
Group I
This group is for people with neuroendocrine cancer that has developed after previous treatment. This is treatment emergent neuroendocrine cancer.
There are two different treatment options for group I.
It is a randomised part of the trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You have 1 of the following:
Carboplatin and etoposide are chemotherapy drugs.
You have pembrolizumab and the chemotherapy drugs as a drip into a vein.
Closed groups
The following groups are now closed and no more people can join. These groups are as follows.
Group A have pembrolizumab and olaparib.
Group B have pembrolizumab, and prednisolone.
Group C have pembrolizumab and enzalutamide.
Group D have pembrolizumab, abiraterone acetate and prednisolone.
Having treatment on the trial
The team tell you when you will have treatment and for how long. This is different for each group.
For people having pembrolizumab this is for up to two years, as long as it is working, and the side effects are not too bad.
If you are having pembrolizumab or MK-7684A and all signs of your cancer disappear () you might be able to stop these drugs early, after at least 8 doses. You and your doctor will talk about this at the time.
If the scan shows that your cancer is getting worse, the trial team will ask you to have another scan 4 or 6 weeks later. This is to confirm that your cancer is getting worse. Depending on the results of the second scan you might be able to continue with the study drugs or your doctor will advise other treatment options for you.
You may be able to have more treatment with pembrolizumab or MK-7643A. Your doctor can tell you more.
Research samples
You give blood samples and tissue samples during the trial. Your doctor will tell you how many and how often.
The trial team use these samples to:
The team are also using blood tests to look at:
Future research
The trial team would like to collect some samples for future research if you are in a certain group. They will ask your permission for this. You can say no and still take part in the trial.
You see a doctor and have some tests before taking part in the trial. These include:
You have a heart scan ( – if you are in group E or F.
Each takes around 3 weeks. So, during treatment you see the doctor around every 3 weeks for bloods and to see how you are. You might be contacted by, or have to see, the study team more regularly depending on which treatment group you are in.
You might have your blood pressure measured in between hospital visits by a local healthcare professional.
Scans during treatment
You have an MRI scan or CT scan, and bone scan:
After treatment and follow up
You have an end of treatment visit. You have some tests at this visit, these include:
You see the team 30 days after the last dose of the study drug. This is to see how you are getting on, have some blood tests and an ECG (groups E&F only).
In the follow up stage, your doctor will let you know when you need to come into the hospital or when they will contact you. The trial team would like to keep in contact to see if there have been any changes and find out how you are feeling.
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 MK-7684A can affect the immune system. They 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 most common side effects of pembrolizumab are:
We have more information about the side effects of pembrolizumab.
The trial team gives you separate information on the possible side effects of MK-7684A if you have this treatment. You can ask any questions you have before you start.
We have information about the possible side effects of lenvatinib.
In general, the most common side effects of chemotherapy are:
We have more information on the side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Johann DeBono
Merck Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.