A trial of MK-1026 for some types of blood cancer (MK1026-003)
Cancer type:
Status:
Phase:
This trial is looking at MK-1026 for blood cancer that has come back or following treatment that has stopped working.
More about this trial
Sometimes blood cancer comes back or the treatment stops working. So doctors are looking for treatments to help this group of people.
In this trial they are looking at a new drug called MK-1026. It is a type of cancer growth blocker called a bruton tyrosine kinase inhibitor (BTKi). It stops signals that cancer cells use to divide and grow. Doctors think it might help people with blood cancer that started in 
. These are called B cells. But doctors aren’t sure how well it will work, so they want to find out more.
This trial is in 2 parts. The part you join depends on the type of blood cancer you have and when you join the trial.
Part 1 is looking at the best dose of MK-1026 to have. Part 2 is testing this dose in more people.
The main aims of the trial are to find out:
- the best dose of MK-1026 to have
- how safe it is
- how well treatment works
- what happens to MK-1026 in the body
- how treatment affects quality of life
Who can enter
Please note, there are several treatment groups or cohorts. Each group has specific entry conditions and we haven’t listed them all.
The trial team check if you are suitable to join the trial and which group you can join. They can tell you more about this.
The following bullet points summarise some of the main entry conditions. 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
To join part 1 you must have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
You may be able to join part 2 if you have one of the following blood cancers:
- chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The treatments for CLL and SLL are the same.
- Richter’s transformation
- mantle cell lymphoma
- marginal zone lymphoma
- follicular lymphoma
- Waldenstrom's macroglobulinaemia
As well as the above all of the following must also apply. You:
- have cancer that has come back or treatment has stopped working
- are up and about for at least half the day but might not be able to work (performance status of 0, 1 or 2)
- can swallow medication and keep it down
- 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 cancer that has spread to the brain or spinal cord
- have had MK-1026 or a similar drug in the past. Your doctor will know this.
- have had another cancer treatment in the last 4 weeks before you join the trial or it hasn’t cleared your body
- have side effects from past treatment. You can join the trial if the side effects are mild or you have moderate to bad numbness and tingling in your hands or feet (
peripheral neuropathy) . - have had another cancer in the last 3 years. You can join if you have
basal cell skin cancer , squamous cell skin cancer or carcinoma in situ (CIS ) - are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of having the first dose of treatment in this trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have a problem with your heartbeat. You doctor checks this before you join the trial.
- have had surgery and the side effects aren’t better
- are having treatment with certain drugs. These include drugs such as paclitaxel, digoxin and rifampicin. Your doctor will know this.
- have an active hepatitis B or hepatitis C infection or another active infection that needs treatment. You might be able to take part if you have HIV, your doctor will check your suitability.
- have a problem with your
digestive system that means you can’t absorb the drug - have any other medical condition or mental health problem that would affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are sensitive to MK-1026 or anything it contains
- have a problem with drugs or alcohol
- are pregnant or breastfeeding
| As well as the above there are specific entry conditions 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. |
Trial design
This phase 2 trial is taking place worldwide.
The team need about 30 people to join part 1 and about 466 people to join part 2. This includes about 20 people from the UK.
Part 1 is the dose escalation part of the trial. The first few people taking part have the lowest dose. The next few people have a higher dose if they don’t have any side effects. And so on, until the team find the best dose to give.
In part 2 they test this dose in more people. There are 8 groups or cohorts. The group you join depends on your cancer type. The team check what previous treatment you had and any changes () in the cancer cells. This is to see if you are suitable to join the trial.
Everyone has MK-1026. It is a tablet that you take once a day. The team tell you how many tablets to take. You have treatment for as long as it is working and the side effects aren’t too bad.
Blood and tissue samples
The researchers ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They might also ask you to have an extra or give an extra sample of tissue from a .
They plan to use the samples to:
- see how well treatment is working
- look at
genes to understand more about blood cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - measure MK-1026 in the body
You need to agree to give most of the samples to take part in the trial. There are a few you can say no to. The team can let you know more about this.
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during treatment
- at set times after treatment
The questionnaire asks 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:
- blood tests
- urine tests
- a
physical examination - heart trace (ECG)
Depending on your cancer type you might also need:
- a bone marrow test
- to give a sample of cancer tissue from a
lymph node - a CT scan
- a PET scan
You see the doctor for a check up:
- once a month for the first 2 years
- once every 3 months after that
You have tests every 3 months during treatment to see how well it is working. These might include scans or bone marrow tests. The trial team can tell you more about the scans or tests you might have.
Follow up
When you stop treatment, you see the trial team one month later for a check up.
You then see them every 3 months. You do this until your cancer gets worse or you start another cancer drug.
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.
MK-1026 is a new drug. Just over 100 people have had MK-1026. So we don’t know what all the side effects are. The most common side effects we know about so far include:
- feeling sick
- taste changes
- feeling weak and tired (fatigue)
- an increased risk of infection
- skin rash
Your doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask them any questions you may have.
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 Elizabeth Phillips
Supported by
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
