PORT
Research type
Research Study
Full title
Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T cell lymphoma
IRAS ID
235979
Contact name
Timothy Illidge
Contact email
Sponsor organisation
University College London
Eudract number
2017-000433-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 0 days
Research summary
Cutaneous T-cell lymphoma (CTCL) is a type of cancer that affects the network of vessels and glands spreading throughout the body, mainly the skin (Mycosis Fungoides [MF]), though it can also affect the blood, lymph nodes and other internal organs (Sezary Syndrome [SS]). It is caused by white blood cells, called T cells, growing in an uncontrollable way within the body.
There are a number of standard treatments that are currently used in treating CTCL, depending on the stage of disease. Though the cancer often responds to these current treatments, there are instances where the cancer does not respond or where it returns. There is, therefore, a need to find alternative treatments that are more effective, leading to lasting responses and improved quality of life.
PORT study will investigate whether radiotherapy in addition to pembrolizumab, a type of immunotherapy designed to ‘re-awaken’ the immune system, will improve response to treatment.
In this study, 46 adult (aged ≥ 18 years) patients with CTCL, whose disease has either come back or not responded to treatment, will be given pembrolizumab with radiotherapy. Pembrolizumab will be given every 3 weeks for a maximum of 2 years. patients will also receive radiotherapy at week 12.
Patients will be seen regularly during treatment and then yearly until the last patient entering the study completes their 2 year 5 months follow-up.
The study will be conducted at NHS hospitals and is expected to last 5 years and 5 months.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0077
Date of REC Opinion
16 Apr 2018
REC opinion
Further Information Favourable Opinion