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.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2846
• Date of registration: 11/04/2011
• Primary sponsor: European Association of Urology
• Public title: 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.
• Scientific title: A randomized, double blind, placebo controlled phase II trial to evaluate the safety and efficacy of recMAGE-A3 + AS15 ASCI in patients with MAGE-A3 positive muscle invasive bladder cancer after cystectomy: A European Association of Urology Research Foundation Randomized Phase II Clinical Trial. - MAGNOLIA
• Date of first enrolment: 30/6/2011
• Target sample size: 273
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2846
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Raymond Schipper

• Name: Wim P.J. Witjes

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Muscle invasive bladder cancer, Radical cystectomy

Intervention(s)

Patients will be randomized for recMAGE-A3 + AS15 or placebo on 2:1 ratio. 5 doses will be administered at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months.

Primary Outcome(s)

Evaluation of the clinical efficacy in terms of Disease Free Survival of treatment versus placebo in patients with bladder cancer with MAGE-A3 expression after cystectomy.

Secondary Outcome(s)

1. Overall survival;

2. Disease-free specific survival (DFSS);

3. Distant metastasis-free survival (DMFS);

4. Safety of recMAGE-A3 + AS15 ASCI;

5. Immune response to recMAGE-A3 + AS15 ASCI;

6. Translational research on gene signature and expression.

Secondary ID(s)

2010-01

Source(s) of Monetary Support

GSK BIO, Belgium