BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients

Inclusion criteria

• Male or female patient with histological confirmation of NMIBC
• Full recovery from surgery (TUR) from 1 to 6 weeks
• Karnofsky performance status of 60% or more
• Laboratory parameters for vital functions should be in the normal range
• Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration
• Male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment

Exclusion criteria

• Muscle invasive bladder cancer
• Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available
• Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
• Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial)
• History of severe allergic reactions to vaccines or unknown allergens
• Patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.

The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted

• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
• Lack of availability for immunological and clinical follow-up assessment
• For female patients of childbearing potential: positive urine or serum pregnancy test or lactating
• Known positive HIV test, HBV, HCV.