Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
City of Hope
Duarte, California, United States
UCLA
Los Angeles, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met.
Time frame: 24 weeks
The monitoring of clinical activity, immune response and safety across multiple doses.
Time frame: 24 weeks
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Emory University
Atlanta, Georgia, United States
The Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Carolina's Medical Center / Blumenthal Cancer Center
Charlotte, North Carolina, United States
Barrett Cancer
Cincinnati, Ohio, United States
...and 4 more locations