NCT00033904

Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer

A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (planned)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Detailed description

Primary Objective: * The primary objective of this study is to determine whether subjects randomized to receive adjuvant HSPPC-96 after surgical resection of locally advanced renal cell carcinoma at high risk of recurrence, have improved recurrence-free survival as compared to subjects with no adjuvant treatment. Secondary Objective: * Determine whether subjects randomized to receive HSPPC-96 have improved survival as compared to subjects with no adjuvant treatment. * Further characterize the safety profile of HSPPC-96.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	autologous human tumor-derived HSPPC-96

Timeline

• Start date: 2000-06-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2002-04-15
• Last updated: 2012-09-07

Locations

76 sites across 11 countries: United States, Austria, Belgium, Canada, France, Israel, Norway, Poland, Spain, Sweden, United Kingdom