No registrations found.
ID
Source
Brief title
Health condition
Muscle invasive bladder cancer, radical cystectomy
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Proof-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.
Study objective
The disease free survival will be prolonged in MAGE-A3 positive patients treated with recMAGE-A3.
Study design
FPI: August 2011;
LPFV: July 2013;
LPLV: November 2016.
Intervention
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.
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2708 |
| NTR-old | NTR2846 |
| Other | EAU-RF : 2010-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |