Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)

Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity

This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.

The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.

Inclusion Criteria:

• In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.

Exclusion Criteria:

• Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.