NCT00678119

Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment

A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination With Sunitinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Argos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.

Detailed description

The purpose of this study is to investigate an anticancer immunotherapeutic, AGS-003, when used in combination with sunitinib (the treatment regimen) in a single-stage, Phase II design in subjects with previously untreated advanced stage RCC after nephrectomy/excisional biopsy/metastasectomy. AGS-003 is formulated using mature DCs co-electroporated with CD40L IVT RNA and autologous total tumor RNA

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AGS-003	Dendritic cell Immunotherapeutic
DRUG	Sunitinib	An approved drug for the treatment of RCC

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-05-15
• Last updated: 2013-07-15

Locations

14 sites across 2 countries: United States, Canada