BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer
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.