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

Phase 3

Terminated

• Conditions: Metastatic Renal Cell Carcinoma; Advanced Renal Cell Carcinoma; Renal Cell Carcinoma
• Interventions: Drug: Standard Treatment; Biological: AGS-003

• Registration Number: NCT01582672
• Lead Sponsor: Argos Therapeutics

Brief 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.

Study Timeline

• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-23
• Study Start: 2012-11
• Status Verified: 2017-06
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard Treatment	Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
AGS-003 + Standard Treatment	AGS-003	Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.

Primary Outcome Measures

Name	Time	Method
Overall Survival	From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study	Duration from randomization to death

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	From date of subject randomization to date of progression; assessed up to 42 months
Monitor treatment emergent adverse events between both arms	From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months	Compare adverse events between both arms.
Tumor Response	From date of subject randomization to date of progression; assessed up to 42 months	Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.