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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28470

Enrollment

273

Registered

2011-04-11

Start date

2011-06-30

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle invasive bladder cancer, radical cystectomy

Interventions

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 du

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactRaymond Schipper

EAU Research Foundation

r.schipper@uroweb.org+31263890677

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)