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PORT: a phase 2 trial testing pembrolizumab and radiotherapy in people with relapsed or refractory T-cell skin lymphoma

This phase two trial is testing a targeted drug called pembrolizumab in combination with radiotherapy in people with mycosis fungoides or Sézary syndrome who have not responded to treatment (refractory lymphoma) or whose lymphoma has come back (relapsed) after previous treatment.

You can share the following ClinicalTrials.gov Identifier with your medical team so they can find out more about the trial: NCT03385226


Trial aim and background

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

People over 18 with mycosis fungoideas or Sézary syndrome who have previously had at least one course of systemic (whole body) treatment may be eligible to enter this trial.


Location

Recruitment is taking place in the following UK locations:

University Hospital Birmingham, Birmingham
Velindre Cancer Centre, Cardiff
University Hospital Coventry, Coventry
Beatson West of Scotland Cancer Centre, Glasgow
Guy's & St Thomas', London
The Christie, Manchester
Freeman Hospital, Newcastle
Nottingham City Hospital, Nottingham
Churchill Hospital, Oxford
Southampton University Hospital, Southampton
Clatterbridge Cancer Centre, Wirral


Further information

More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: clinicaltrials.gov/ct2/show/NCT03385226

Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.