The PERM Study
Research type
Research Study
Full title
Randomised Phase II Trial of Pembrolizumab and Radiotherapy in Melanoma: The PERM Study.
IRAS ID
164114
Contact name
James Larkin
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2014-004065-25
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Around 13,000 patients are diagnosed with melanoma in the UK each year and that number is growing quicker than any other cancer. About 20% of patients will see their cancer return following their initial treatment and at present would survive a median time of 9-12 months. In recent years, the development of new effective drugs has revolutionised the treatment of advanced melanoma, However, response rates are still low and new therapeutic approaches are needed.
This is a phase II study to look at the effectiveness and safety of the combination of a new drug called pembrolizumab plus radiotherapy compared to pembrolizumab alone. The purpose of this study is to see if the addition of radiotherapy to pembrolizumab is better than pembrolizumab alone by measuring how long these treatments can control the growth of the cancer. Also it will assess if by adding radiotherapy we can see its effects not only in the tumour that has had radiotherapy but also in other tumours in the rest of the body.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1141
Date of REC Opinion
23 Jul 2015
REC opinion
Favourable Opinion