Purpose of trial
The aim of this trial is to find out if pembrolizumab in combination with radiotherapy is safe and effective for people with relapsed or refractory mycosis fungoides or Sézary syndrome.
Pembrolizumab is a type of targeted drug called a checkpoint inhibitor. It blocks an interaction between lymphoma cells and your own immune cells that turns your immune cells off. Blocking this interaction turns your immune cells on and allows them to recognise and destroy the lymphoma cells.
Everybody in this trial has pembrolizumab every 3 weeks. It is given as an intravenous infusion (a drip into your vein). You carry on having pembrolizumab for up to 2 years unless you stop responding to it or develop troublesome side effects.
Twelve weeks after starting pembrolizumab, you start radiotherapy. You have three doses of radiotherapy over 3 days. If your lymphoma gets worse before week 12, you stop pembrolizumab and start radiotherapy sooner.
You are seen in hospital every 3 weeks for as long as you are on pembrolizumab. After you stop pembrolizumab, you are followed-up once a year until the end of the trial.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 46 people are needed for this trial.
You may be able to enter if:
- You have mycosis fungoides or Sézary syndrome.
- Your lymphoma is at stage 1B to 4B.
- You have at least one skin lesion that is suitable for radiotherapy treatment.
- Your lymphoma can be measured by the tests used in the trial.
- You have previously had at least one course of systemic (whole body) treatment for your lymphoma.
- Any previous treatments you have had are no longer in your system. This means waiting 1 week after treatment with topical therapies (therapy applied directly to your skin); 2 weeks after treatment with phototherapy, local radiotherapy, retinoids, HDAC inhibitors, denileukin diftitox or oral steroids; 4 weeks after systemic treatment with chemotherapy, antibody treatment or targeted drugs; and 12 weeks after treatment with alemtuzumab.
- You have not experienced side effects of previous treatments within the last 2 weeks (except peripheral neuropathy).
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are 18 or over.
You won’t be able to enter if:
- You have any health problems, including infections or lung disease, that your doctor thinks might make it unsafe for you to have the trial treatment.
- You still have significant side effects from your previous treatment.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have had a solid organ transplant.
- You have an autoimmune disease or other illness affecting your immune system (except stable hypothyroidism or type 1 diabetes).
- You have a psychiatric illness or other condition that might affect your ability to take part in the trial.
- You are taking part in another clinical trial, or have taken part in one in the last 4 weeks.
- You are taking or have taken certain other drugs.
- You have had a live vaccine in the last 30 days.
- You have HIV, hepatitis C or hepatitis B.
- You have another cancer that is getting worse or being treated (except certain localised cancers).
- You are pregnant or breastfeeding.
- You are allergic to pembrolizumab or any of its ingredients.
More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03385226