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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.


- candidate number9322
- NTR NumberNTR2846
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2011
- Secondary IDs2010-01 EAU-RF
- Public TitleClinical 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 TitleA 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.
- ACRONYMMAGNOLIA
- hypothesisThe disease free survival will be prolonged in MAGE-A3 positive patients treated with recMAGE-A3.
- Healt Condition(s) or Problem(s) studiedMuscle invasive bladder cancer, Radical cystectomy
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-jun-2011
- planned closingdate1-nov-2016
- Target number of participants273
- InterventionsPatients 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 outcomeEvaluation 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 outcome1. 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.
- TimepointsFPI: August 2011;
LPFV: July 2013;
LPLV: November 2016.
- Trial web sitehttp://www.uroweb.org/research/projects/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Raymond Schipper
- CONTACT for SCIENTIFIC QUERIES Wim P.J. Witjes
- Sponsor/Initiator European Association of Urology
- Funding
(Source(s) of Monetary or Material Support)
GSK BIO, Belgium
- PublicationsN/A
- Brief summaryProof-of-Concept for activity was reached in a double-blind, randomized, placebo-controlled Phase II in NSCLC. A second Proof-of-Concept was obtained indepently in a Phase II study in metastatic melanoma. The data to date suggest that the investigational MAGE-A3 ASCI is well-tolerated..
Since MAGE-A3 tumour antigen is expressed in approximately 40% of patients with bladder cancer, the possibility that recMAGE-A3 may also be an efficient therapy in patients with bladder cancer needs to be explored.
- Main changes (audit trail)
- RECORD11-apr-2011 - 11-aug-2012


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