Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer

Inclusion criteria: * Female or male patients, 18-65 years of age, with newly diagnosed, histologically confirmed p16- and HPV16-positive oropharyngeal squamous cell carcinoma with locoregional advanced disease including the following stages: * T2N2-3, M0 * T3N0-3, M0 * T4N0-3, M0 * Primary tumour accessible for biopsy and intratumoural administration * No evidence of distant metastatic disease (HPV16-positive secondary tumours are permissible) * Karnofsky 100 - 70 (ECOG 0 or 1) * Life expectancy of at least 6 months * Normal screening ECG or screening ECG with no clinically significant findings requiring immediate treatment, as judged by the investigator * Women of childbearing potential: Negative serum pregnancy test at screening * Agree to use a reliable form of contraception until the end of the study treatment period. * Provides written informed consent Exclusion criteria: * Distant metastases * Secondary, not HPV16-associated, malignancy * History of malignancy other than the target malignancy to be investigated in this trial unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period * Clinically significant out of range haematological, renal or hepatic laboratory tests which cannot be explained by the underlying disease * Any vaccination within 1 week before day 0 * Active significant viral infections including influenza, CMV, and EBV within 4 weeks before receiving study treatm…