Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma. (TORAVA)

NCT00619268 Phase 2 COMPLETED

The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer. Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.

Details

Lead sponsor	Centre Leon Berard
Phase	Phase 2
Status	COMPLETED
Enrolment	160
Start date	2008-02
Completion	2012-02

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

• Temsirolimus
• Bevacizumab
• Sunitinib
• Interferon alpha-2a

Primary outcomes

• progression-free rate — at 48 weeks post-treatment

Countries

France