This trial is a phase III randomised, open-label, multicentre clinical trial.
The primary outcome measures, which are used to assess the main aim of the study, are the length of time until the cancer gets worse (progression-free survival) in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and overall survival.
Secondary outcome measures are objective response rate, duration of response, quality of life, and safety and tolerability of the pembrolizumab plus epacadostat combination as measured by adverse events and discontinuation of study medication.
The trial is looking to recruit 630 people from the UK, Australia, Brazil, Canada, Chile, France, Germany, Hungary, Ireland, Japan, Republic of Korea, New Zealand, Norway, Poland, Russian Federation, Spain, Taiwan, Turkey, Ukraine, and the USA.
The study is for people diagnosed with kidney cancer that has spread to the tissues surrounding the kidney (locally advanced) and to other parts of their body (metastatic), and who have not received any previous treatment for their kidney cancer, other than surgery (nephrectomy).
Patients will be allocated randomly into two treatment groups with equal numbers of patients. One group of patients will be given pembrolizumab infusions into a vein in the arm (intravenously) every 3 weeks and epacadostat tablets to take by mouth twice a day. The other group of patients will be given standard treatment with either sunitinib (taken by mouth once a day for 4 weeks, with a 2 week break) or pazopanib (taken by mouth once a day). Each group will be on the study for up to 3 and a half years (42 months) and will be given study medication until they are no longer benefiting from the treatment or unable to tolerate the side effects.