Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
NCT01582672 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462
Last updated 2018-06-14
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.
Conditions
- Advanced Renal Cell Carcinoma
- Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
Interventions
- 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.
Sponsors & Collaborators
-
Argos Therapeutics
lead INDUSTRY
Principal Investigators
-
Robert Figlin, MD, FACP · Cedars-Sinai Medical Center
-
Christopher G Wood, MD, FACP · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2018-04-30
- Completion
- 2018-04-30
Countries
- United States
- Canada
- Czechia
- Hungary
- Israel
- Italy
- Spain
- United Kingdom
Study Locations
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