47
Participants
Start Date
October 1, 2012
Primary Completion Date
December 12, 2018
Study Completion Date
December 12, 2018
Indoximod
Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T
Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo
Given in same manner as Indoximod; 1200 mg per day by mouth.
New York Presbyterian/Weill Cornell Medical Center, New York
Penn State Milton S. Hershey Medical Center, Hershey
Masonic Cancer Center, University of Minnesota, Minneapolis
University of Illinois Medical Center, Chicago
Masonic Cancer Center, University of Minnesota
OTHER