ARISER study design and objectives

'In the ARISER study the drug WX-G250 (preliminary trade name RENCAREX^®) is tested in the adjuvant treatment setting for RCC after the tumor (all or part of the kidney) has been surgically removed. The adjuvant setting means that the drug will be given soon after surgery to patients in whom no remaining visible cancer has been found, but who have a high risk of recurrence of the tumor. Recurrence means either that the tumor returns in the same location as the original primary tumor or in another location after the primary tumor has been removed. Many tumors recur within 15–18 months after surgery and 85% of tumor recurrence occurs within 3 years.

In clinical studies it is often necessary to include a so-called comparator arm (a group of patients also referred to as the control group) in which the disease is treated with standard therapy. There is no registered therapy for this stage of disease; consequently, the control group in the ARISER study will receive placebo. A placebo is a ‘dummy’ drug that looks exactly like WX-G250 but which contains no active substance.

The ARISER study is recruiting more than 850 patients from over 150 centers in more than 10 countries.