This trial is a phase III randomised, blinded, parallel arm, multicentre clinical trial.
The primary outcome measure, which is used to assess the main aim of the study, is the time from randomisation to the return of the cancer (disease-free survival, DFS) as assessed by the investigator.
Secondary outcome measures are overall survival, the safety of pembrolizumab as measured by adverse events, time to local recurrence of the cancer, the movement of pembrolizumab throughout the body, and quality of life.
The trial is looking to recruit 950 people from the UK, Argentina, Australia, Brazil, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Italy, Japan, Republic of Korea, Poland, Russian Federation, Spain, Taiwan, USA.
The study is for people diagnosed with kidney cancer (clear cell or sarcomatoid clear cell RCC) and who are at intermediate to high risk of their cancer returning after surgery, and who have not received any previous treatment for their kidney cancer, other than surgery (nephrectomy or metastasectomy).
Patients will be randomly allocated to two treatment groups:
- Pembolizumab
- Placebo (a salty liquid)
Patients in the pembrolizumab group will be given 200 mg pembrolizumab infusions into a vein in the arm (intravenously) every 3 weeks for up to 17 doses (approximately 12 months). Patients in the placebo group will be given an infusion of salty liquid (placebo) into a vein in the arm (intravenously) every 3 weeks for up to 17 doses (approximately 12 months).
