A trial looking at a drug called MK-5684 for prostate cancer that has spread

Cancer type:

Prostate cancer
Secondary cancers

Status:

Open

Phase:

Phase 1/2

This trial is looking at a drug called MK-5684 for people with prostate cancer that has spread to another part of the body and has started to grow again. 

It is open to people whose cancer started to grow again:

  • while having hormone treatment or 
  • after having surgery to remove their testicles 

More about this trial

Prostate cancer that has spread is called advanced prostate cancer or metastatic prostate cancer. 

Prostate cancer needs hormones Open a glossary item to grow and spread. Doctors use hormone treatment to stop the advanced cancer from growing and spreading. You might also have chemotherapy such as docetaxel or cabazitaxel. Unfortunately, this does not always work and the advanced cancer can start to grow again. 

Researchers are looking for ways to help people in this situation. 

MK-5684 is a targeted cancer drug Open a glossary item that reduces the amount of hormones the body makes. We know from laboratory studies Open a glossary item that MK-5684 might help people with advanced prostate cancer that has started to grow despite hormone treatment.

There are 2 parts to this trial. In the first part the team will find the best dose of MK-5684 to give with:

In the second part people will have one of the following:

  • MK-5684 by itself
  • MK-5684 and olaparib
  • MK-5684 and cabazitaxel 

The aims of this trial are to find out:

  • the best dose of MK-5684 to give with other treatments
  • how well MK-5684 works by itself and with other treatments
  • more about the side effects of MK-5684 by itself and in combination with other treatments
  • how MK-5684 by itself and in combination with other treatments affects quality of life Open a glossary item

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 advanced prostate cancer that is an adenocarcinoma type.
  • Your cancer got worse while having treatment within the past 6 months. Or you have had an operation to remove both testicles and your cancer has got worse within the past 6 months. If you were having or had certain hormone treatment Open a glossary item or chemotherapy Open a glossary item treatment the timing is different. Your doctor can tell you more about this. 
  • You have had a bone scan Open a glossary item, CT scan Open a glossary item or an MRI scan Open a glossary item that shows your cancer has got worse. 
  • You are taking medication that lowers or blocks the male sex hormone androgen. If you are taking a LH blocker Open a glossary item and have not had surgery to remove the testicles, you must have started them at least 4 weeks before going into a treatment group (randomisation Open a glossary item) and continue taking them during the trial. Ask your doctor about this.
  • If you are having medication to help your bones such as a bisphosphonate Open a glossary item or denosumab, you must have started it and be on a stable dose for at least 4 weeks before randomisation. 
  • You have satisfactory blood test results. 
  • You are willing to use reliable contraception during the trial and for a time after if there is any chance you could get someone pregnant. 
  • You have a previous tissue sample (biopsy Open a glossary item) taken that the trial team can ask for and use. 
  • You are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
  • You 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 ongoing side effects from previous treatment. This is apart from mild side effects. Ask your doctor about this.
  • have had certain medications for your cancer such as finasteride, oestrogen, cyproterone or any other cancer medication that reaches your whole body within 4 weeks of randomisation. This is including medication as part of another clinical trial. You can ask your doctor if this applies to you. 
  • have had herbal preparations that lower the PSA level Open a glossary item within 4 weeks of randomisation
  • have had more than 1 course of chemotherapy Open a glossary item that included a taxane drug Open a glossary item for the cancer that has spread and the cancer had got worse during treatment or after this treatment
  • have active cancer that has spread to the brain, spinal cord or the thin tissue surrounding the brain. You can join if you have had treatment for this as long as it is stable for at least 4 weeks before joining and you have stopped taking steroids Open a glossary item for at least 2 weeks before starting the trial treatment.
  • had a superscan bone scan. Your doctor will know about this. 
  • had another cancer in the past 3 years that needed treatment or got worse. This is apart from successfully treated non melanoma skin cancer Open a glossary item, a carcinoma in situ (CIS) Open a glossary item, apart from CIS of the bladder.

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

  • are not able to swallow tablets or capsules. Or you have a digestive system problem Open a glossary item that affects how well your body absorbs tablets or capsules.
  • have or had a problem with the way the pituitary gland Open a glossary item works
  • have diabetes that is not well controlled
  • have high blood pressure that is not well controlled
  • have had a heart attack within the past 6 months or any other significant heart problem Open a glossary item
  • have a myelodysplastic syndrome (MDS), or acute myeloid leukaemia (AML). Or your doctor thinks you might have signs and symptoms of them.
  • have or had problems with how well your adrenal glands Open a glossary item work for example Addison’s disease
  • have or had inflammation of the lungs (pneumonitis) and had steroids to treat it
  • had major surgery and have not recovered within 28 days of randomisation
  • are on hormone therapy for a thyroid gland Open a glossary item problem and the dose is not stable within 6 months of starting the trial treatment 
  • had a whole blood transfusion within 120 days of randomisation. For packed red blood cells Open a glossary item and platelets Open a glossary item it is 28 days before randomisation. Your doctor will know this. 
  • have radiotherapy within 2 weeks of starting the trial treatment or you have ongoing side effects from radiotherapy. For radiotherapy to control symptoms it is 1 week, unless it was for brain and spinal cord symptoms.
  • have medication, including herbal preparations, that affect the CYP enzymes Open a glossary item within 2 weeks of starting the trial treatment 
  • have an active autoimmune disease Open a glossary item that needed treatment in the past 2 years. This is apart from certain ones that your doctor will know about.
  • have HIV unless it is well controlled with medication. You cannot join if you have or had Kaposi’s sarcoma or Multicentric Castleman’s Disease.
  • have active hepatitis B and hepatitis C or any other active infection
  • have any other medical condition, mental health condition or other circumstances that could affect you taking part

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

  • want to start a family in the near future while you might be in the trial
  • have a live vaccine Open a glossary item within 30 days of starting the trial treatment. The seasonal flu vaccine and the COVID-19 vaccine are not live vaccines.
  • are allergic to any of the treatments, or any of their ingredients, used in this trial 

Trial design

This is an international phase 1 and phase 2 trial. 

Phase 1
For the phase 1 part, the team need up to 30 people worldwide.

This part of the trial is not open to recruitment in the UK.

The team want to find the best dose of MK-5684 to take with other treatments. The best dose is the one with the fewest side effects. 

There are 3 groups with up to 10 people in each group. Which group you go into depends on your previous treatment and when you join the trial. The groups are:

  • MK-5684 and olaparib
  • MK-5684 and cabazitaxel 

The team need to find the best dose of olaparib and cabazitaxel to have with MK-5684. To do this everyone will have the same dose of MK-5684. The team will then change the dose of olaparib and cabazitaxel until they find the best dose of each to give with MK-5684.

The team will use the best dose of MK-5684 for each group in the phase 2 part. 

Phase 2
For the phase 2 part the team need up to 220 people worldwide including 18 from the UK.

There are 3 groups in this phase. Which group you go into depends on your previous cancer treatment and when you join the trial. The 3 groups are:

  • MK-5684
  • MK-5684 and olaparib
  • MK-5684 and cabazitaxel 

MK-5684 is a tablet. Your doctor will tell you how many you take. You take them twice a day every day. 

MK-5684 can affect the way the adrenal glands Open a glossary item work. The adrenal glands make steroids Open a glossary item and hormones Open a glossary item that control key functions of the body.  For example, they help to control blood pressure. Taking MK-5684 can cause a drop in how much steroids and hormones the adrenal glands make. To make sure you have enough of these steroids and hormones you will take some medication to replace them. Your doctor will tell you more about this. 

You continue to have MK-5684 as long as it is helping and the side effects are not too bad.

Olaparib is a tablet. Your doctor will tell you how many you take. You take them twice a day every day. You continue to have olaparib as long as it is helping and the side effects are not too bad.

You have cabazitaxel as a drip into a vein. You have it in cycles of treatment Open a glossary item. Each cycle is 3 weeks. You continue to have up to 10 cycles of cabazitaxel as long as it is helping and the side effects are not too bad.

Samples for research
The team take blood samples. Where possible they take these samples when you have blood taken as part of your routine care. 

The team will ask for piece of a previous tissue sample (biopsy Open a glossary item) when you join the trial. If this is not available they will ask for a new biopsy. 

They will use these samples to:

  • find out what happens to MK-5684 in the body
  • find out how MK-5684 affects the body
  • look for substances (biomarkers Open a glossary item) that might show how well treatment is working and why it works better for some people and not others

Quality of life
You fill in questionnaires:

  • before starting treatment
  • during treatment
  • after treatment

The questions ask about:

  • your general health and wellbeing
  • side effects

These are quality of life questionnaires

Hospital visits

You see the doctor to have a physical examination Open a glossary item and tests before taking part. These tests include:

People having MK-5684 only or having MK-5684 and olaparib 
During treatment you see the doctor every 2 weeks for 3 months and then once every 4 weeks. This is to see how you are, for blood tests and other tests.

People having MK-5684 and having MK-5684 and cabazitaxel
During treatment you see the doctor:

  • once a week for a month then
  • 2 or 3 times a month while you are still having cabazitaxel then
  • once a month 

This is to see how you are, for blood tests and other tests.

Follow up
Everyone sees the doctor 4 weeks after stopping MK-5684. This is to see how you are, for blood tests and other tests. 

You might have further follow up appointments, depending on your situation. The trial team can give you more information about this. 

After this, your doctor will tell you how often they want to see you as part of your routine care.

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.

Your doctor will tell you about the possible side effects of the treatments used in the trial and answer any questions you might have before you agree to take part.

MK-5684 is a new drug and there might be side effects we don’t know about yet. The side effects we do know about are:

  • feeling weak and lack of energy (fatigue)
  • muscle spasms and aches
  • difficulty falling asleep, staying asleep or both
  • shortness of breath
  • a cough
  • change to the blood pressure 
  • swelling of the legs or feet, or both
  • a loss of appetite
  • diarrhoea
  • feeling or being sick
  • weight gain
  • low blood pressure and feeling very weak that is caused by a decrease in the adrenal gland making stress hormones
  • increase of a substance, picked up in a blood test, that might mean inflammation of the pancreas
  • decrease of salt in the blood
  • increase or decrease of potassium in the blood
  • increase of sugar in the blood

Some of the side effects can be severe or life threatening. Some of the side effects can be because people might be taking too much or too little of the medication to replace the hormones that are reduced by taking MK-5684. Contact the hospital helpline or your doctor if you have any of these side effects. 

We have information about the side effects of:

Location

Birmingham
Cambridge
Glasgow
London
Preston

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Robert Jones

Supported by

Merck Sharp and Dohme LLC

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19945

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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