Phase III ARISER Study

Overview
Study Objectives and Design
Main Inclusion Criteria: RCC Patients at High Risk of Recurrence
Exclusion Criteria
Participating Countries
Links and Further Information

Overview

Renal Cell Carcinoma (RCC) is the most common form of kidney cancer. 20-40% of RCC patients have no evidence of metastases at the time of first diagnosis, but have a high risk of relapse within 2 years after the surgical resection of the affected kidney. Currently, there is no approved treatment for adjuvant therapy of RCC after surgery. There is a highly unmet medical need for adjuvant treatment of RCC patients post surgery. The Phase III ARISER study with RENCAREX®* in non-metastatic RCC is a clinical study with the objective of demonstrating safety and efficacy of a medical treatment to address this need.

Study Objectives and Design

ARISER (Adjuvant RENCAREX®* Immunotherapy Phase III trial to Study Efficacy in non-metastatic RCC) is a double-blind, placebo-controlled Phase III study to assess the effect of adjuvant treatment with RENCAREX®* on disease-free survival and overall survival in RCC patients with a high risk of recurrence following surgery (nephrectomy). The study also assesses safety and patients‘ quality of life.

ARISER is recruiting over 800 patients from over 140 centers in more than 15 countries. Patients receive a once-weekly infusion of RENCAREX®* (WX-G250) or placebo for 24 weeks. Those patients receiving the active drug (RENCAREX®*) receive a loading dose of 50 mg WX-G250 in week 1, and weekly doses of 20 mg during weeks 2-24.