A trial of pembrolizumab and radiotherapy for people with T cell lymphoma of the skin (PORT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Lymphoma

Non-Hodgkin lymphoma

Secondary cancers

Status:

Closed

Phase:

Phase 2

This trial is for people with a type of lymphoma that started in the T cells of the skin. It is called cutaneous T cell lymphoma (CTCL).

It is for people with CTCL that has come back or got worse after at least one type of treatment that reached the whole body (systemic).

More about this trial

Cutaneous T cell lymphoma (CTCL) is a rare type of lymphoma that affects the skin. The most common types of CTCL are:

mycosis fungoides
sesary syndrome

Chemotherapy and targeted drugs are possible treatments for CTCL. These treatments can control the cancer for some time. But the cancer can start to grow again or spread to other parts of the body. This is called relapsed or progressive disease.

Doctors are looking for new ways to help people with relapsed or progressive disease. In this trial, they are looking at pembrolizumab and radiotherapy.

Pembrolizumab (Keytruda) is a type of immunotherapy Open a glossary item

. It blocks a protein called PD-1. This stimulates the immune system Open a glossary item

to find and kill cancer cells.

Radiotherapy uses high energy x-rays to kill cancer cells. It is already a possible treatment for people with CTCL.

The main aim of this trial is to find out whether pembrolizumab and radiotherapy help people with CTCL.

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 mycosis fungoides or sesary syndrome CTCL that affects more than 10% of your skin (stage 1B to stage 4B). Your doctor can tell you more about this
your cancer came back or got worse after at least one treatment that reached your whole body (systemic treatment) such as interferon and chemotherapy
you have had a tissue sample of your cancer taken in the past 6 months (archival tumour sample) or you are willing to have a new sample taken
doctors think that radiotherapy is a suitable treatment for you
there is at least one area of cancer that doctors can measure
you have satisfactory blood test results
you are well enough to carry out all your normal activities apart from heavy physical work (performance status of 0 or 1)
you are willing to use reliable contraception during treatment and for at least 4 months afterwards if there is any possibility that you or your partner could become pregnant
you are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You:

have lymphoma spread in the brain or the spinal cord
have had pembrolizumab or any other similar drug
have had radiotherapy or a type of cancer treatment using light (photo dynamic therapy ) in the past 2 weeks
have had chemotherapy or a targeted drug in the past 4 weeks
still have moderate or severe side effects from previous cancer treatment apart from numbness and tingling in fingers and toes
have had treatment directly to your skin (topical treatment) in the last week
have had a monoclonal antibody in the last 15 weeks (about 4 months) and you still have moderate or severe side effects from it
have had a transplant with somebody else's stem cells (an allogeneic transplant)
took part in another clinical trial looking at a new drug or device in the last 4 weeks
have another cancer that needs treatment apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated

Medical conditions

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

have had an autoimmune disease that needed treatment in the past 2 years, apart from treatment to replace something that the body makes such as insulin or thyroxine
have a problem with your immune system or you have had an organ transplant and you need to take medication to damp down your immune system
have had steroids in the last 7 days apart from inhalers, creams, steroid injections into a joint or you take 10mg of prednisolone or less a day
have heart problems such as congestive heart disease, abnormal heart rhythm or angina that isn’t controlled
have an active infection
have had, or currently have, lung problems such as pneumonitis
have had, or currently have tuberculosis
have HIV
have hepatitis B or hepatitis C
have had an organ transplant
take an amount of drugs or alcohol that is a concern for your doctors
have any other medical condition or mental health problem that doctors think could affect you taking part

Other

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

are pregnant or breastfeeding
are sensitive to pembrolizumab or anything it contains
have had a live vaccine in the last 30 days

Trial design

This is a phase 2 trial. Researchers hope that around 46 people will agree to take part.

Everyone has the same treatment. You have pembrolizumab as a drip into your vein every 3 weeks. It takes about 30 minutes each time you have it. You continue to have pembrolizumab for as long as the treatment is helping you and the side effects aren’t too bad. You can have treatment with pembrolizumab for up to 2 years.

You start radiotherapy after the 5th pembrolizumab treatment. This is usually about 3 months after the start of treatment. You have 3 radiotherapy treatments (fractions) in total.

If your cancer gets worse before the 5th pembrolizumab treatment, you start radiotherapy as soon as possible and you stop pembrolizumab treatment.

Blood tests

You have extra blood tests as part of this trial. Doctors want to look for certain proteins (biomarkers) that can help to tell how well the treatment is working.

You have the extra blood tests before the start of treatment.

Doctors might also ask you to have extra blood tests:

after the 3rd and the 5th pembrolizumab treatment
if your cancer gets worse or disappears

You don’t need to agree to have extra blood tests after the start of pembrolizumab if you don’t want to. You can still take part in this trial.

Tissue sample

Doctors ask to use a sample of cancer they took during a biopsy Open a glossary item

or surgery (archival tumour sample). You need to give a new sample of tissue if there isn’t a suitable sample available that is less than 6 months old.

Doctors may also ask you to give new tissue samples:

after the 3rd and the 5th pembrolizumab treatment
if your cancer gets worse or disappears

You don’t need to agree to give extra tissue samples if you don’t want to. You can still take part in this trial.

Quality of life

Everybody taking part completes quality of life questionnaires before the start of treatment and then:

at set times during the trial
when you finish treatment

The questionnaires ask about how you have been feeling and what side effect you have had.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination
blood tests
urine test
a CT scan
photographs of the cancer lesions on the skin
tests to check how well your lungs work (lung function tests)

You see a doctor before each pembrolizumab treatment. You have blood tests and a physical examination every time you see them.

You have a CT scan before the 1st pembrolizumab treatment. You then have a CT scan at the 5th and 9th pembrolizumab treatment

This continues for as long as the treatment is helping you and the side effects aren’t too bad. You can have pembrolizumab for up to 2 years.

You see the trial doctor every time you receive your treatment. When you finish treatment, or if your cancer gets worse, you see or speak with the trial team every year.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start treatment.

Pembrolizumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.

The most common side effects of pembrolizumab are:

skin rashes, itching and changes to your skin colour
loose or watery poo (diarrhoea)
feeling sick
cough
pain in your joints, back and tummy (abdomen)
high temperatures
headaches and dizziness
taste changes
thyroid problems that can cause tiredness and feeling cold
low levels of salt in your body that may cause you to feel tired, have headaches and muscle cramps