Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer

ADXS-504 will be administered as monotherapy at 2 dose levels. Subjects who are assigned to receive Dose Level 1 (DL1) will be administered ADXS-504 at a dose of 1×107 CFU q4 weeks (±3 days) from Week 1 to Week 21. Subjects who are assigned to receive Dose Level 2 (DL2) will be administered ADXS-504 at a dose of 1×108 CFU q4 weeks (±3 days; Week 1 to Week 21). All 3-6 subjects must be enrolled in DL1, and DL1 must be confirmed safe, before enrollment for DL2 may begin. For both dose levels, these doses are followed by maintenance dosing at each respective dose level given every 12 (q12) weeks (±3 days) for 4 doses for overall total of 10 doses of the study treatment. If DL1 is deemed to exceed the MTD, dose reduction of ADXS-504 to DL-1 (1×106 CFU) may proceed. Dose level -1, intermediate dose levels or expansion of a cohort may also be further evaluated if recommended by the Investigator and Advaxis in future amendments.