NCT01582672

Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Argos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

Detailed description

This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.

Conditions

• Advanced Renal Cell Carcinoma
• Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Standard Treatment	Standard treatment for Renal Cell Carcinoma
BIOLOGICAL	AGS-003	Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2012-04-23
• Last updated: 2018-06-14

Locations

125 sites across 8 countries: United States, Canada, Czechia, Hungary, Israel, Italy, Spain, United Kingdom