Clinical study to evaluate the safety and efficacy of recMAGE-A3 in patients from which the bladder is removed due to muscle invasive bladder cancer.

1. Aged >= 18 years, either sex;

2. Histologically confirmed MAGE-A3 positive;

3. Written informed consent has been obtained prior to any protocol-specific procedure;

4. TNM classification of surgically removed specimen: Stage T2,3 N0 or N1 or N2 and M0 or Stage T4 N0 M0;

5. No residual disease/metastasis max 9 weeks prior to randomization;

6. Patient is fully recovered from surgery within 9 weeks following cystectomy;

7. Adequate bone-marrow reserve, renal function and hepatic function;

8. WHO performance status 0 – 1 at the time of randomization;

9. Female patients must be of non-childbearing potential or must practice adequate contraception.

1. Previous/concomitant malignancies at other sites;

2. Any anti-cancer treatment;

3. Radiotherapy of the abdominal or pelvic region, within 6 months prior to randomization;

4. Women who are pregnant or breast feeding;

5. Known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C;

6. History of allergic reactions likely to be exacerbated by the study investigational product;

7. Immunosuppressive or immunodeficient condition or potential immune-mediated disease (vitiligo excl.);

8. Patient has received a major organ allograft;

9. Concomitant treatment with systemic corticosteroids /immunosuppressive agents;

10. Investigational or non-registered medicinal products other than the study medication;

11. Psychiatric/addictive disorders compromising the ability to comply with the study procedures;

12. Other medical problems that limit compliance with the study/expose the patient to unacceptable risk;

13. The patient uses alternative treatments eg. plantextracts.