Ph3 Placebo-Controlled Trial-Adjuvant MK-3475 in RCC Post Nephrectomy
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)
IRAS ID
225698
Contact name
Stefan Symeonides
Contact email
Sponsor organisation
Merck Sharp & Dohme Ltd
Eudract number
2016-004351-75
Duration of Study in the UK
5 years, 3 months, 14 days
Research summary
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, responsible for approximately 90–95% of cases. RCC accounts for 2-3% of all adult cancers, representing the 7th most common cancer in men and 9th most common cancer in women.
Worldwide, there are estimated 209,000 newly diagnosed cases of RCC and estimated 102,000 deaths per year. Approximately 90% of renal tumours are RCC and approximately 80% of these are of clear cell histology.
This is a phase III, randomised, double-blind, placebo-controlled trial of a study drug pembrolizumab in the post-surgical treatment of participants with RCC and have intermediate-high risk, or high risk of the cancer spreading or whose cancer had previously spread but was completely removed by surgery.
The purpose of the trial is to evaluate how effective and safe pembrolizumab is compared with placebo (dummy drug).
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug, pembrolizumab, has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
Approximately 950 male and female adults aged 18 years and above will be randomly assigned in a 1:1 ratio to receive either placebo or pembrolizumab (200 mg), administered intravenously every 3 weeks for up to 1 year. After the treatment participants will be followed up for overall survival.
The study is funded by Merck Sharp & Dohme Limited and will take place at 8 study centres in the UK.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0254
Date of REC Opinion
17 Jul 2017
REC opinion
Further Information Favourable Opinion