Spots Global Cancer Trial Database for Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced HNSCC

Study Description

Brief Summary: The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead tumor cells from the patient itself and genetically modified cells within a capsule. The whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9 the capsules are removed again. The patients are then followed-up for 5 years.

Detailed Description: Patients with advanced HNSCC after platinum-based palliative chemotherapy have a poor prognosis, with no well-defined standard treatment and a survival between 6 to 9 months. MVX-ONCO-1 is a patient specific, cell-based, active immunotherapy, where the patient's immune response to tumor cells is stimulated and/or increased by triggering an immune response against the patients' cancer cells. Rationale for this trial is: 1. HNSCC: there is a clear medical need in this patient population, 2. Relapsing HNSCC often have accessible tumor tissue, 3. HNSCC is considered an immunogenic tumor. This phase II study is a first step towards a potentially innovative immunotherapy for HNSCC. MVX-ONCO-1 is composed of: 1. An immune-modulator (GM-CSF: granulocyte-macrophage colony stimulating factor) released from an immuno-protected, encapsulated, allogeneic, genetically modified cell line (MVX-1), and 2. Irradiated, autologous tumor cells as source of antigen. Each treatment consists of two macrocapsules containing the MVX-1 cell line implanted subcutaneously and lethally irradiated autologous tumor cells injected subcutaneously. Eligible patients will receive a treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each pair of macrocapsules is removed after 1 week, and the last implanted capsules are removed in week 9. The patients are then followed-up for 5 years. The project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 880194.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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