Cisplatin-based Chemotherapy Combined With P16_37-63 Peptide Vaccination in Patients With HPV-positive Cancers

Inclusion Criteria: * Histologically confirmed, advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancer cancer * HPV positivity as tested by HPV genotyping from paraffin embedded tumor tissue using Linear Array HPV Genotyping test from Roche Diagnostics Germany GmbH * Diffuse expression of p16INK4a in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue using the CINtec p16INK4a histology kit * Planned cisplatin-based chemotherapy with an expected duration of at least 2 months. A carboplatin-based therapy may be selected as an alternative by investigators choice * Expected survival of at least 3 months * Full recovery from prior surgery, chemotherapy or radiation therapy (except for alopecia, fatigue or neurotoxicity of grade 1 or 2 * ECOG performance status 0, 1 or 2 * The following laboratory results: Neutrophil count ≥ 1.5 x 109/L Lymphocyte count ≥ 0.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin \< 2mg/dL * Patient´s written informed consent for participation in the trial Exclusion Criteria: * Prior treatment with P16\_37-63 peptide * Clinically significant heart disease (NYHA Class III or IV) * Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders * History of immunodeficiency disease or autoimmune disease * Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available * Known HBV, HCV or HIV positiv…