Personalized, cell-based antitumor immunization with MVX-ONCO-1, combining subcutaneous implantation of irradiated autologous tumor cells and encapsulated allogeneic cells engineered to release GM-CSF: a single arm Phase II trial

Summary:

Head and neck squamous cell cancer has the sixth highest incidence and ranks eighth in deaths worldwide. For patients with recurrent and/or metastatic disease, the prognosis is extremely poor. While response rates of 30 to 40% have been achieved with chemotherapy, survival estimates remain at six to nine months. Second-line chemotherapy remains even more dismal with response rates around 3%. Thus, new therapies for patients with recurrent or metastatic disease are critically needed. This phase II study will assess the effectiveness of MVX-ONCO-1, an immunotherapy consisting of a vaccine made of the patient’s dead tumor cells and an implantable immune boosting agent. Encapsulation cell technology will prevent degradation of the immune boosting agent by the patient’s body and as result will enhance the immune-stimulatory effect of the vaccine.

Trial Registration: ClinicalTrials.gov Identifier: NCT02999646