Phase I/II dose escalation study of OncoVexGM-CSF and chemoradiotherapy (CRT) in untreated stage III/IV squamous cell cancer of the head and neck (SCCHN)

6018 Background: OncoVEXGM-CSF is a gene deleted (ICP34.5-/ICP47) oncolytic HSV-1 that encodes human GM-CSF. OncoVEXGM-CSF causes direct oncolytic tumour cell destruction and immune activation by releasing tumour antigens and GM-CSF, effects that may co-operate with CRT to increase loco-regional control in SCCHN. Methods: Patients (pts): Stage III/IVA SCCHN, N1-N3, ECOG 0–1, normal haematologic, biochemical, immune function. Pts received CRT (70 Gy/35 fractions with concomitant cisplatin 100 mg/m2 (d 1, 22, 43) and dose-escalating (106, 106, 106, 106 pfu/mL [cohort 1]; 106, 107, 107, 107 [cohort 2]; 106, 108, 108, 108 [cohort 3]) OncoVEXGM-CSF by intratumoral injection (d 1, 22, 43, 64). Pts underwent neck dissection 6–10 weeks after CRT. Primary endpoints were safety and recommended dose/schedule for future study. Secondary endpoints were anti-tumor activity, viral replication and HSV antibody levels. Results: 17 pts were treated, 9 at the top dose (15 males, median 58 years). DLT and MTD were not reache...