Protocol SAKK 11/16: Personalized and cell-based anti-tumor immunization MVX-ONCO-1 in advanced head and neck squamous cell carcinoma. A single arm, open label, multicenter phase II trial

Project

Protocol SAKK 11/16: Personalized and cell-based anti-tumor immunization MVX-ONCO-1 in advanced head and neck squamous cell carcinoma. A single arm, open label, multicenter phase II trial

Completed - recruitment closed · 2020 until 2023

Rordorf Tamara

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Brustzentrum St.Gallen, Medizinische Onkologie und Hämatologie

Status

Completed - recruitment closed

Start Date

2020

End Date

2023

Financing

SAKK

Study Design

Phase II

Keywords

Hand and neck cancer; personalized immunotherapy

Partner

Dr. Veronika Nagy, Dr. Karen Nestor, Dr. Sabrina Ebinger, Prof. Dr. Markus Joerger, Frau Jessica Hollenstein, Dr. Nikolaus Wagner

Labels

head and neck tumors

Brief description/objective

MVX-ONCO-1 is a form of active specific immunotherapy, a process by which the patient’s immune response to tumor cells is stimulated and/or augmented. MVX-ONCO-1 is a patient specific, cell-based, immunotherapy composed of: a. An immune-modulator (GM-CSF: granulocyte-macrophage colony stimulating factor) released from an immuno-protected, encapsulated, allogeneic, genetically modified cell line (MVX-1), and b. Irradiated, autologous tumor cells as source of antigen. The IMP (MVX-ONCO-1) is a medication without marketing authorization in Switzer-land or any other market. MVX-ONCO-1 is an ex-vivo gene therapy (GMO), a transplantation product regulated by the Transplantation Act (Art. 49) in accordance to the Therapeutic Products Act (TPA), the Human Research Act (HRA) and the Clinical Trials Ordinance (ClinO); this trial is classified into clinical trial as a category C.