A Randomized, Double-Blind, Placebo-Controlled Study Of Chemotherapy Plus Cetuximab In Combination With VTX- 2337 In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck.
Johns Hopkins Kimmel Cancer Center in Baltimore
To compare the disease response, safety, and survival of patients treated with the standard of care regimen of cisplatin or carboplatin + 5FU + cetuximab in combination with VTX-2337 to those treated with the standard of care regimen alone.
-confirmed squamous cell cancer of the head and neck -locoregionally recurrent or metastatic disease -measurable disease on CT or MRI scan -good physical condition with good blood counts and organ function -no prior systemic anti-cancer therapy unless administered for locally advanced disease and completed at least 6 months prior to start -no surgery, radiation, immunotherapy, or investigational agents within 4 weeks -no active autoimmune disease or known infection with HIV -no treatment with steroids with 2 weeks -no significant heart disease within 6 months prior to start -nasopharyngeal, salivary gland, lip, and sinonasal cancers are not allowed
Standard of care regimen is given every 21 days for a maximum 6 cycles and consists of the following: Cisplatin or Carboplatin given IV on Day 1 of each cycle. 5FU given as a continuous IV infusion via portable pump, on Days 1-4 of each cycle. Cetuximab given IV weekly. Patents will be randomized to receive VTX-2337 or Placebo given as a subcutaneous injection on Day 8 and Day 15 of each 21 day cycle. Following 6 cycles of combination therapy, VTX-2337 or Placebo given as a subcutaneous injection, will be given on Day 8 and Day 22 every 28 days starting with Cycle 7 and continuing until disease progression.
07/01/2015 04:01 AM