The CTC offices are currently closed for refurbishment. Access to trial TMFs and patient records will be limited during this period. We will still be able to receive post during this time, but there may be a small delay in responding to this. Our fax lines may also be subject to disruption. Where possible, please direct all correspondence via email to trial-specific email addresses. We appreciate your patience and understanding.

Due to COVID-19 and current government guidance, UCL CTC staff continue to work remotely with limited access to the office. Please continue to email the trial specific mailbox with any urgent queries. For paper CRF trials, please continue to copy and scan CRFs to the trial inboxes (remove all patient identifiers except Trial Number and Initials) until further notice.

 
Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
15/01/2019
Funder:
MSD
Sponsor:
UCL
Chief Investigator:
Professor Tim Illidge
Recruitment target:
46
EudraCT number:
2017-000433-30
Contact details:
ctc.port@ucl.ac.uk
Lay summary:
PORT
Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T cell lymphoma
Description
Design:

PORT is a multicentre, single arm, phase II trial of pembrolizumab in combination with radiotherapy for patients with relapsed/refractory CTCL.

Treatment:

All registered patients will receive a single IV infusion of pembrolizumab (200mg) given at 3 weekly intervals. At 12 weeks patients will start radiotherapy at a dose of 12Gy in 3 fractions. Patients who progress on pembrolizumab before week 12 will start radiotherapy as soon as possible after progression.  Following completion of radiotherapy, patients will continue pembrolizumab on the same schedule until disease progression or the development of unacceptable toxicity or for a maximum of 2 years, whichever comes earlier.

Key inclusion/exclusion criteria:

Patients must be at least 18 years of age with relapsed, refractory or progressed stage IB-IVB CTCL mycosis fungoides/Sézary Syndrome. They must have at least 1 cutaneous lesion suitable for palliative radiotherapy and at least 1 measurable lesion with a minimum mSWAT score of 10, or 2 or more cutaneous tumours which will not be irradiated but must be measurable.  Patients must have an ECOG performance status of 0-1 and adequate organ function.  Patients cannot have received chemotherapy,targeted small molecule therapy, other monoclonal antibody, prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 therapy or IMP within 4 weeks prior to the first dose of pembrolizumab.  They cannot have CNS involvement, active autoimmune disease requiring systemic treatment in the past 2 years, a history of active TB or received a live vaccine within 30 days prior to the first dose of pembrolizumab. 

Duration of recruitment: 3 years
Aim
The overall aim is to determine whether the addition of radiotherapy topembrolizumab improves response rates.  
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

View map
Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

Copyright © 2021 UCL | Disclaimer | Freedom of Information | Accessibility | Privacy | Cookies | Contact Us