CRS-207: Phase II started
The Sidney Kimmel Comprehensive Cancer Center began the open-label, U.S. Phase II STELLAR trial to compare Aduro’s GVAX Pancreas cancer vaccine plus its IV CRS-207 in combination with Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) vs. GVAX Pancreas plus CRS-207 alone in 88 patients with metastatic pancreatic cancer patients who have received 1 prior chemotherapy regimen. Patients will receive 6 intradermal injections of GVAX Pancreas on day 1 of cycles 1 and 2, followed by IV CRS-207 on day 1 or 2 of cycles 3-6, with or without Opdivo on day 1 of each cycle. All patients will also receive low-dose cyclophosphamide. The combination of CRS-207 and GVAX Pancreas has breakthrough therapy designation from FDA to treat pancreatic cancer. Stand Up to Cancer (SU2C), Pancreatic Cancer Action Network and BMS are supporting the trial. ...