A trial looking at targeted drugs for mesothelioma (MiST)

Cancer type:

Mesothelioma

Status:

Open

Phase:

Phase 2

This trial is looking at different targeted cancer drugs for mesothelioma that has continued to grow during chemotherapy or came back after chemotherapy.

More about this trial

One of the standard treatments Open a glossary item for mesothelioma is chemotherapy. But there is no standard treatment if the mesothelioma continues to grow during chemotherapy or comes back after.

Targeted cancer drugs work by targeting the differences that help a cancer cell to grow and divide.

In this trial researchers want to know if certain targeted drugs can treat mesothelioma that continues to grow or come back after chemotherapy.

There are 3 stages to this trial.

In the 1st stage the team looks at a piece of tissue from your mesothelioma. They are looking for certain substances (biomarkers Open a glossary item ) in the mesothelioma cells. You might be offered treatment as part of the MiST trial if your mesothelioma cells have 1 or more of these biomarkers.

In stage 2 the researchers are looking at different treatments for mesothelioma. Which treatment you have as part of the trial depends on which biomarkers are in your mesothelioma cells.

In the 3rd stage researchers are looking at the tissue samples (biopsies Open a glossary item ) taken as part of the MiST trial. They are looking at the genes of these samples to try and work out why some drugs work and why some drugs stop working.

The aims of the trial are to find out:

how well these treatments work for mesothelioma
how safe these treatments are
what the side effects are of these treatments

Who can enter

The following bullet points list 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 mesothelioma and there is mesothelioma tissue (biopsy ) available for the trial team
have had chemotherapy that included a platinum drug , such as carboplatin or cisplatin.
have a CT scan that confirms your mesothelioma has grown or spread
are fully active, can do most everything apart from heavy physical work (performance status 0 or 1)
are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply:

you have mesothelioma spread to the brain or spinal cord, you might be able to join if the spread has been treated with radiotherapy more than 28 days before starting treatment in this trial
you have had another cancer apart from successfully treated prostate cancer or cervical cancer that hasn’t come back, basal cell skin cancer or superficial (early) bladder cancer
you have moderate to severe congestive heart failure
your liver isn’t working very well
your kidneys aren’t working very well
you are having long term oxygen
you have any other medical or mental condition your doctor or the trial team think will affect you taking part

Trial design

This is a phase 2 trial. The trial team are looking at different treatments arms.

The 1st treatment arm (MiST1) looked at rucaparib. This arm is now closed. There are enough people taking part.

The 2nd treatment arm (MiST2) looked at abemaciclib. This arm is now closed. There are enough people taking part.

The 3rd treatment arm (MiST3) is open for people to join.
The 4th treatment arm (MiST4) is open for people to join.

MiST3
In MiST3 researchers are looking at the drugs bemcentinib and pembrolizumab.

Bemcentinib is a cancer growth blocker. It works by blocking a protein that cancer cells need to grow and survive.

Bemcentinib is a capsule. You have 4 capsules once a day for 3 days. You then have 2 capsules once a day for the rest of your treatment.

You take bemcentinib on an empty stomach. You shouldn’t eat for at least 1 hour after taking it. You continue taking bemcentinib as long as it is working and the side effects aren’t too bad.

Pembrolizumab is an immunotherapy. It works by helping the immune system Open a glossary item kill cancer cells. You have pembrolizumab as a drip into a vein.

You have pembrolizumab every 3 weeks. Each 3 week period is called a cycle of treatment Open a glossary item . You can have up to 35 cycles of treatment as long as it is working and the side effects aren’t too bad.

You have a diary to write down when you take your bemcentinib and any side effects you might have. You must take this to all your hospital appointments for the doctor or trial team to see.

MiST4
In MiST4 researchers are looking at the drugs atezolizumab and bevacizumab.

Atezolizumab is an immunotherapy. It works by helping the immune system recognise cancer cells.

Bevacizumab is a monoclonal antibody. It works by stopping the cancer cells from developing new blood vessels. And this can help stop the growth of cancer cells.

You have atezolizumab and bevacizumab as a drip into a vein. You have them once every 3 weeks. This is a cycle of treatment.

You have 8 cycles of treatment of each drug as long as they are working and the side effects aren’t too bad. At the end of the 8 cycles if they are still working you might be able to continue taking the treatments. Your doctor will talk to you about this.

Samples
The team will ask your permission to obtain a piece of cancer tissue from when you were diagnosed. If this isn’t available you must agree to give a fresh sample (biopsy Open a glossary item ).

You might be asked to give another sample of tissue if your treatment stops working. You don’t have to agree to this if you don’t want to. You can still take part in the trial.

You also give blood samples during the trial.

Researchers will use these samples to find out more about mesothelioma and how to treat it.

You also give a poo sample before the start of treatment and at times during treatment. Researchers use these samples to help them understand more about the effect immunotherapies have on the natural bacteria Open a glossary item found in your bowel.

Hospital visits

You have some tests before taking part. These tests include:

a physical examination
blood tests
heart trace (ECG )
CT scan
chest x-ray
urine sample
poo sample
heart scan (ECHO ) if you are in MiST3

You see the doctor often while having treatment. This is to see how you are and for blood tests.

You have a CT scan every 6 weeks for 24 weeks and then every 12 weeks.

In MiST3 you see the doctor:

a month after finishing treatment then at
3 months and
6 months

You have a heart scan (ECHO) at 6 months.

In MiST4 you see the doctor a month after finishing treatment and then at 6 months.

After this your doctor will tell you how often they want to see you.

Side effects

You have an emergency card (like a business card) that has the contact details of the trial team. You should contact them if you have any side effects.

Pembrolizumab and atezolizumab affect the immune system. They may cause inflammation in different parts of the body which can cause serious side effects. These 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, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy.

Side effects for MiST3
The most common side effects of pembrolizumab are:

rash, itching, dry skin, red skin or loss of skin colour
diarrhoea
feeling sick
infusion related reactions – while having or just after having pembrolizumab you might feel dizzy, faint, flushed, get a rash, have a fever, feel short of breath or feel pain at the infusion site
an increased level of thyroid hormones (hyperthyroidism) – this can cause feelings of anxiety and anger, trouble sleeping, weakness, trembling, sweating, tiredness, diarrhoea or constipation, tummy (abdominal) pain, bowel pain (colitis) and loss of appetite
painful joints, muscle and bones
stiff and swollen joints
loss of strength
general swelling of the body
high temperature (fever), flu like symptoms, chills