GENEVA UNIVERSITY HOSPITALS: 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

 

Year of Grant: 2015

Location: Switzerland

 

Cancer remains a major cause of morbidity around the world. Despite the availability of current drug therapies, a vast majority of individuals suffering from cancer with local infiltration or metastasis still die within 3 years from their malignancy. 

 

As cancer tumor is unique with its own set of molecular/genetic alterations, generating abnormal proteins, each anomaly is a potential target (antigen) for an efficient immune system. In addition to the right targets, potent tumor specific active immunotherapy needs very strong immune booster or adjuvant to efficiently stimulate the immune system.

 

This phase II trial will evaluate the efficacy of a novel, patient specific cell-based MVX-ONCO-1 immunization strategy using encapsulation cell technology that is not only personalized but can also be applied to any cancer type. Adopting a subcutaneous (introduced beneath the skin) formulation, it combines patient specific antigens, which is obtained from the patient’s own cancer cells, with the potent adjuvant known as the Granulocyte Macrophage Colony-stimulating Factor (GM-CSF).

 

A first for men, the phase I clinical trial was recently completed with initial data showing a very good safety/feasibility profile with no serious adverse effects related to the experimental immunotherapy; there were only mild local reaction < Grade 2 during implantation. Interesting clinical observations from an earlier phase I trial were also made in 7/13 evaluable patients, which showed shrinkage in lung metastasis, prolonged survival in ovarian and neuro-endocrine tumors and stable disease in metastatic pancreatic cancers treated while progressing after > 2 lines of treatments.

 

The phase II trial will be non-randomized, open, multicentric, evaluating efficacy in 39 patients with head and neck squamous cell carcinoma (HNSCC) either locally advanced or metastatic after failure of one line of treatment. Primary endpoint is overall survival at 6 months. Trial also includes translational research with extensive immuno-monitoring (before, during and after treatment) and quality of life parameters.