Pembrolizumab in advanced renal cell carcinoma
Research type
Research Study
Full title
A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427)
IRAS ID
211110
Contact name
Tom Waddell
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2016-000589-47
Duration of Study in the UK
5 years, 0 months, 0 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. Surgery, embolisation (blocking of blood-flow to cancer cells), chemotherapy (cancer medicines) or radiation therapy have substantially improved the likely outcome of patients with RCC. However, the outcome is very poor in advanced or spreading (metastatic) cancers.
This phase II, single arm, open label trial will study how effective and safe pembrolizumab is as first-line treatment for advanced/metastatic RCC.
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. Pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
Approximately 255 male and female adults aged 18 years/above with locally advanced/metastatic RCC will receive 200 mg of pembrolizumab (as intravenous solution) every 3 weeks for approximately 2 years.
Two groups of patients will be recruited, each with a different subtype of RCC: clear cell RCC and non clear cell RCC. The main purpose of the study for both groups is to evaluate the proportion of patients who achieved a complete response (disappearance of all target tumours) or partial response.
The study is funded by Merck Sharp & Dohme Limited and will take place at six study centres in the UK.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0606
Date of REC Opinion
21 Sep 2016
REC opinion
Further Information Favourable Opinion