Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients

An Open Label, Dose Escalation Safety and Tolerability Trial of the Combination of s.c. Recombinant Human IL-21 (rIL-21) and Sunitinib (Phase 1) Followed by an Open Label Stratified Randomized 2-arm Trial of rIL-21 Plus Sunitinib Versus Sunitinib Alone (Phase 2a) in Subjects With Stage IV Renal Cell Carcinoma

This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib.

The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.

Inclusion Criteria:

• Histologically verified and surgically incurable stage IV Renal Cell Carcinoma
• ECOG performance status of 0 or 1 (i.e. good performance status)
• Life expectancy of at least 3 months

Exclusion Criteria:

• Prior systemic therapy for metastatic disease
• Radiotherapy within the last 4 weeks prior to start of treatment
• Receipt of any investigational drug within 3 months of starting treatment
• History of any other active malignancy within five years prior to enrolment