This trial is a phase III, randomised, open-label clinical trial.
The primary outcome measures, which are used to assess the main aim of the study, are the length of time that the cancer does not grow or spread after the start of study treatment (progression free survival, PFS) and how long people survive following treatment (overall survival, OS).
Secondary outcome measures are:
- The proportion of patients with a reduction in the size of their tumour (objective response rate, ORR) at the end of treatment, either a complete response or a partial response
- The duration of the response to treatment
- Safety of the treatments in terms of the incidence and type of side effects, and the number of patients who discontinue the study due to side effects
- Quality of life on belzutifan or everolimus, in terms of physical functioning and deterioration of disease
The trial is looking to recruit 736 people from the UK, Brazil, Canada, Chile, Columbia, Czechia, Denmark, Finland, France, Greece, Hong Kong, Hungary, Italy, Japan, South Korea, Norway, Russia, Spain, Sweden, Taiwan, Turkey, Ukraine, and the USA.
You will be randomly allocated to one of the following two treatment groups:
- Belzutifan tablets, 120 mg once a day
- Everolimus tablet, 10 mg once a day.
Belzutifan and everolimus are tablets that you take once a day, continuously. If you are unable to tolerate the treatment, the tablets will be stopped.
