Immunotherapy with anti-PD in stage III melanoma
Research type
Research Study
Full title
Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group.
IRAS ID
177116
Contact name
Paul Lorigan
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc
Eudract number
2014-004944-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug pembrolizumab, in people who have recently had node metastases of skin melanoma removed, to see if it reduces the chances of melanoma returning in patients at a high risk of recurrence.
About 900 people will participate in the study.
Eligible participants will be assigned randomly to receive either the study drug or placebo. This will be double-blinded, meaning that neither they nor the study doctor will know which they are receiving.
Patients whose melanoma recurs will be unblinded so they and the investigator will know which treatment they were receiving. Patients who were receiving the placebo will be offered to cross over to the study drug, after signing an additional consent.
A number of assessments will be performed during the study including physical examinations, measurements of body weight, blood pressure and pulse rate, blood tests, urine tests, electrocardiograms and quality of life questionnaires. These assessments are performed as part of the evaluation to determine if the study drug is effective and safe. Disease status will be determined using either MRI or CT scans.
The study will be run at approximately 9 centres in the UK and is sponsored by MSD.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0690
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion