A trial of MK-1026 for some types of blood cancer (MK1026-003)

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

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 white blood cells Open a glossary item . 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 (mutations Open a glossary item ) 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 bone marrow test Open a glossary item or give an extra sample of tissue from a lymph node .

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: