
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at MK-1026 for blood cancer that has come back or following treatment that has stopped working.
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:
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:
As well as the above all of the following must also 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 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 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:
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:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
Depending on your cancer type you might also need:
You see the doctor for a check up:
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.
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:
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Beth Phillips
Merck, Sharp & Dohme
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.