Phase III ARISER
ENGLISH DEUTSCH
Overview
Study Objectives and Design
Main Inclusion Criteria: RCC Patients at High Risk of Recurrence
Exclusion Criteria
Status
Links and Further Information
Overview
Clear cell renal cell carcinoma (ccRCC) 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 ccRCC after surgery. There is a highly unmet medical need for adjuvant treatment of ccRCC patients post surgery. The Phase III ARISER study with RENCAREX® in non-metastatic ccRCC is a clinical study with the objective of demonstrating safety and efficacy of a medical treatment to address this need.
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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 patient’s quality of life.
ARISER has recruited 864 patients from over 140 centres in 14 countries. Patients received a once-weekly infusion of RENCAREX® or placebo for 24 weeks. Those patients receiving the active drug (RENCAREX®) receive a loading dose of 50 mg in week 1, and weekly doses of 20 mg during weeks 2-24.
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Main Inclusion Criteria: RCC Patients at High Risk of Recurrence
The study has enrolled patients with:
- Prior nephrectomy of primary renal cell carcinoma (RCC) with documented clear cell histology
- ECOG score of 0 or 1
- No evidence of macroscopic or microscopic residual disease
- Surgery no later than 12 weeks before study entry (randomisation).
In addition, patients must show one of the following “High Risk” criteria:
- Tumour stages > T3aN0/NXM0
- Any tumour stage with N+ and M0
- Tumour stage T1b/T2N0/NXM0 and grading G ³ 3 (Fuhrman or any other nuclear grading system with at least 3 grades)
Main Exclusion Criteria
Patients are excluded from this study with:
- Prior chemotherapy/immune therapy/radiotherapy within the past 5 years
- Pre-exposure to murine or chimeric antibody
- Prior organ transplantation
- History of prior malignancies within the past 5 years, except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ
- Any unrelated illness, which can significantly jeopardise patients’ clinical status
Status
The positive interim analysis for futility by the Independent Data Monitoring Committee (IDMC) after 100 relapses was published in December 2007. Recruitment of the study was completed mid 2008, and the last patient finished the 24-week treatment in February 2009.
In January 2011 WILEX announced that over 340 recurrences have now been reported by the local trial centres. Therefore the process for the interim analysis of efficacy for RENCAREX® has been started. The process involved the central analysis of the data from all 864 patients by independent radiologists and entering all data in databases and quality control. In November 2011 the Independent Data Monitoring Committee (IDMC) has recommended cancelling the interim analysis and performing the final DFS analysis now. WILEX therefore plans to complete the final analysis. In February 2012 the company announced that the FDA approved the protocol amendment for the pivotal Phase III ARISER trial with RENCAREX® needed to cancel the interim analysis and perform the final analysis of disease free survival (DFS). Final DFS analysis and results are expected in Q4 2012.
Links and Further information
More information on the study, participating countries and sites are available on the following websites: www.cancer.gov/clinicaltrials or www.clinicaltrials.gov, then search under: “WX-2003-07-HR”
For further information you may also contact: clinical.trials@wilex.com
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