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.
Suspended
- Conditions
- Muscle invasive bladder cancer, radical cystectomy
- Registration Number
- NL-OMON28470
- Lead Sponsor
- EAU Research Foundation, Arnhem, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 273
Inclusion Criteria
1. Aged >= 18 years, either sex;
2. Histologically confirmed MAGE-A3 positive;
Exclusion Criteria
1. Previous/concomitant malignancies at other sites;
2. Any anti-cancer treatment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. Overall survival;<br /><br>2. Disease-free specific survival (DFSS);<br /><br>3. Distant metastasis-free survival (DMFS);<br /><br>4. Safety of recMAGE-A3 + AS15 ASCI;<br /><br>5. Immune response to recMAGE-A3 + AS15 ASCI;<br /><br>6. Translational research on gene signature and expression.