Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC

Inclusion Criteria for pre-registration: * Written informed consent according to ICH/GCP regulations before pre-registration * Histologically confirmed diagnosis of head and neck squamous carcinoma (oral cavity, pharynx, larynx), Stage III/IV in recurrent or metastatic stage. Patients with local relapse for whom a curative treatment is available cannot be enrolled. Furthermore, all patients should have no other therapeutic option left. * At least one line of prior anticancer therapy for recurrent or metastatic disease. Patients with locally advanced disease experiencing local relapse within 6 months of last dose of curative intended, platinum-based chemo-radiation with or without prior surgery can also be included. * Primary tumor and/or metastasis amenable for partial/total surgery or tap * Measurable or evaluable disease according to RECIST 1.1 criteria * Patients age ≥ 18 years * WHO performance status 0-2 * Adequate hematological values: neutrophils ≥1x10\^9/L, platelets ≥70x10\^9/L * Adequate hepatic function: bilirubin ≤2 x ULN; AST and ALT and AP ≤2.5 x ULN (except for patients with liver metastasis: ≤5 x ULN) * Adequate renal function (creatinine clearance \>40mL/min/1.73m\^2, calculated according to the corrected formula of Cockcroft-Gault * Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant after pre-registration, during trial treatment and during the 6 months thereafter. A negative blood pregnancy test before inclusion into the trial is required for all women with child-bearing potential * Men agree not to father a child during trial treatment and during 6 months thereafter Exclusion Criteria for pre-registration: * Known or suspected CNS metastases or active leptomeningeal disease * History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of T1-2 prostate cancer Gleason score \<6 (PSA\<10 ng/mL), adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer * Participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks of the pre-registration * Concomitant use of other anti-cancer drugs * Planned radiotherapy (other than symptom control) * Severe or uncontrolled cardiovascular disease uncontrolled hypertension (sustained systolic blood pressure \> 150 mm Hg and/or diastolic \> 100 mm Hg despite antihypertensive therapy) * History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to pre-registration * Any history of HIV * Known history of HTLV-1, HTLV-2, or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment * Known severe allergy to reagents in the study product (MVX-ONCO-1) * Systemic disease other than cancer that is not controlled by approved medication * Patient with active autoimmune disease * Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent corticosteroid. Note: In acute situations prednison exceeding 20mg/day or equivalent(day is allowed during 7 days) * Women who are pregnant or breast feeding * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications Inclusion criteria for registration: * Primary tumor and/or metastasis amenable for partial/total surgery or tap and subsequent cell harvest \> 26x10\^6 cells * Measurable or evaluable disease according to RECIST 1.1 criteria * WHO performance status 0-2 * Baseline QoL forms have been completed * Adequate hematological values: neutrophils ≥1x10\^9/L, platelets ≥70x10\^9/L * Adequate hepatic function: bilirubin ≤2 x ULN; AST and ALT and AP ≤ 2.5 x ULN (except for patients with liver metastasis: ≤5 x ULN) * Adequate renal function (creatinine clearance \>40 mL/min/1.73m\^2, calculated according to the corrected formula of Cockcroft-Gault * Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant after registration, during trial treatment, and during the 6 months thereafter. A negative blood pregnancy Exclusion criteria for registration: * Known or suspected CNS metastases or active leptomeningeal disease * Concomitant use of other anti-cancer drugs * Planned radiotherapy (other than symptom control) * Any one full cycle of anti-cancer chemotherapy treatment in the 3 preceding weeks of the registration * Systemic disease other than cancer, that is not controlled by approved medication * Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent corticosteroid. Note: In acute situations prednisone exceeding 20 mg/day or equivalent is allowed during 7 days * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications * Women who are pregnant or breastfeeding