AGS-003 immunotherapy for kidney cancer

Full Clinical Trial Name

Kidney Cancer (ARGOS AGS-003-007): An international phase 3, randomized trial of Autologous Dendritic cell immunotherapy (AGS-003) Plus standard Treatment of advanced renal cell carcinoma (ADAPT) (2_PRO00000324)

Clinical Trial

  • Cancer

Doctor(s) running this study

Description

Participants will be randomized to one of two study groups: Group II will receive regular medications only for kidney cancer and a Group I will receive regular medications for kidney cancer plus AGS-003, created from a piece of the participant’s tumor along with his or her white blood cells, to activate the immune system. If randomized to Group I, leukapheresis will be done per local procedures and guidelines at a Red Cross Center in Ashley, PA. In most cases, a single leukapheresis session (about 4 hours) will provide enough white blood cells to make the participant’s AGS-003 for the entire study; however, a repeat session may be scheduled (with the participant’s consent). The study will comprise 8 clinic visits and last about 48 weeks, with a final visit scheduled within 30 days after study treatment ends. Participants will be followed by phone every 3 months for at least 3 years.

Eligibility

Inclusion Criteria
  • At least 18 years of age
  • Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study
  • Appropriate performance status
  • Time from diagnosis to treatment less than 1 year
  • Life expectancy of 6 months or greater
  • Adequate organ functions
  • Cannot be pregnant or breastfeeding
  • Must use reliable form of contraception during study and for 12 weeks after the last dose of study drug

Doctor(s) running this study