Active not recruitingPHASE2INTERVENTIONAL

A Trial Assessing the Effect of Pembrolizumab Combined with Radiotherapy in Patients with Relapsed, Refractory, Specified Stages of Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF)/Sezary Syndrome (SS)

This study is looking at a new way to treat certain advanced skin lymphomas (Cutaneous T-cell Lymphoma including Mycosis Fungoides and Sezary Syndrome) that have come back or haven't gotten better with other treatments. It combines a drug called pembrolizumab, which helps your immune system fight cancer, with radiotherapy, a type of radiation treatment. Patients will receive pembrolizumab as a drip every three weeks, and then radiotherapy will be added around week 12. The aim is to see if this combination works safely and effectively. Participants will be monitored closely for up to two years after starting treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

Start

15 Jan 2019

Estimated completion

01 Sep 2025

Cutaneous T Cell Lymphoma Mycosis Fungoides/Sezary Syndrome

What is this study about?

This research study is about finding better treatments for a type of skin cancer called Cutaneous T-cell Lymphoma (CTCL). Specifically, it focuses on two forms of CTCL: Mycosis Fungoides (MF) and Sezary Syndrome (SS). These conditions affect your skin and, for people in this study, have either come back or not responded well to other treatments they've had in the past. The study is investigating a new combination of treatments, hoping to improve outcomes for patients.

The main treatments being tested are pembrolizumab and radiotherapy. Pembrolizumab is a modern type of cancer drug known as an immunotherapy. It works by boosting your body's own immune system to recognise and fight cancer cells. Radiotherapy uses targeted radiation to kill cancer cells and shrink tumours in specific areas. Researchers believe that using these two treatments together might be more effective than using either one alone.

The study wants to see how well this combined approach works and if it's safe for patients. By carefully monitoring participants, the researchers hope to gather important information that could lead to new ways of treating these challenging skin lymphomas for many more people in the future.

Key takeaways

This study combines two treatments: pembrolizumab (immunotherapy) and radiotherapy.
It's for people with specific advanced skin lymphomas (Mycosis Fungoides/Sezary Syndrome) that haven't responded to previous treatments.
Pembrolizumab is given every three weeks; radiotherapy starts around week 12.
The study aims to see if this combination is safe and effective.
Participation involves regular hospital visits and follow-up for up to two years.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a specific type or stage of skin lymphoma called Mycosis Fungoides (MF) or Sezary Syndrome (SS). Your lymphoma should have either returned, not responded to, or progressed after at least one other whole-body treatment. You'll need to have had a recent skin test (biopsy) and have some areas of skin affected by the lymphoma that can be measured and one area that can be treated with radiotherapy.

There are also some general health requirements, including having a good level of physical activity, a life expectancy of at least six months, and healthy organ function. You shouldn't have had certain other cancer treatments or medicines recently. If you are female and could become pregnant, you'll need to have a negative pregnancy test and agree to use contraception during the study. Everyone must be willing to provide their informed consent to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Mycosis Fungoides or Sezary Syndrome that has returned or not responded to previous treatments?
Do you have areas of skin affected by lymphoma that can be measured and treated with radiotherapy?
Are you generally well enough to walk and carry out light activities?
Have you discussed recent treatments with your doctor?
If you could become pregnant, are you willing to use contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive pembrolizumab, an immunotherapy drug, through a drip into your arm every three weeks. Around week 12, you will also start special X-ray treatment called radiotherapy, which will be given in three short sessions, still alongside your pembrolizumab. If your condition gets worse before week 12, you might start radiotherapy sooner. After finishing radiotherapy, you will continue with pembrolizumab every three weeks for up to two years, unless your condition gets worse or you experience side effects that are too much to handle.

Throughout the study, you will have regular check-ups, usually every three weeks, for up to two years to see how you are doing and check for any side effects. If you stop taking pembrolizumab, you will have annual check-ups to monitor your health. The total time you will be involved in follow-up appointments could be several years until the study officially ends.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and your health will be closely monitored by a dedicated medical team. However, there are also potential risks involved. The treatments, pembrolizumab and radiotherapy, can cause side effects, some of which may be serious. You will be told about all known side effects before you decide to join. It's important to remember that the new treatment might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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

Common questions

What is Cutaneous T-cell Lymphoma (CTCL)?

CTCL is a rare type of cancer that starts in white blood cells called T-cells and primarily affects the skin, causing rashes, patches, or tumours.

What is pembrolizumab?

Pembrolizumab is an immunotherapy drug that helps your body's immune system find and fight cancer cells.

What is radiotherapy?

Radiotherapy uses high-energy rays to kill cancer cells and shrink tumours in a specific area of the body.

How often will I need to visit the hospital?

You'll have a main treatment every three weeks, plus additional visits for radiotherapy and regular check-ups, for up to two years.

Can I stop participating in the study early?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.