Squamous Cell Carcinoma Head and Neck Clinical Trial
Official title:
An Individualized Cancer Vaccine for Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase II, Randomized, Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVax™) to Chemotherapy in Subjects with R/M SCCHN .
All accrued subjects will be randomized 2:1 to AlloVax™ (CRCL + AlloStim™) immunotherapy vs.
standard chemotherapy. AlloVax™ is an experimental individualized therapeutic vaccine shown
to be active in this study population.
The standard chemotherapy arm (Arm 1) will receive up to six three-week cycles of
chemotherapy consisting of cisplatin on day 0 of the 3-week cycle at dose 80-100 mg/m2 IV
followed by 1000 mg/m2 IV flurouracil (5FU) on days 1-4 of the cycle.
The immunotherapy arm (Arm 2) will receive immunotherapy (AlloVax™) twice a week for 4 weeks
and then every 4 weeks for an additional 12 weeks.
The study is designed and powered to determine if AlloVax™ is not inferior to the active
chemotherapy control.
;