Lower GI 2017

NCT01671488 phase I/II trial Inclusion: T2 >4cm -T4 or N+ M0, HIV neg Primary Endpoints: SAE, CR at 6 months

q 28 days

ADXS11-001*

MMC 10 mg/m²/d1

5-FU 800/m²/d1-4

Standard RT: 45-65 Gy (IMRT mandatory)

*attenuated Listeria monocytogenes: secretes a protein fused to HPV E7 leading to stimulation of cell-mediated immune response