Overview

This trial is active, not recruiting.

Condition urinary bladder neoplasms
Treatments recmage-a3 + as15 asci, placebo
Phase phase 2
Sponsor European Association of Urology Research Foundation
Collaborator GlaxoSmithKline
Start date August 2011
End date November 2016
Trial size 273 participants
Trial identifier NCT01435356, 2010-024355-85, EAU RF 2010-01, NTR2846

Summary

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections will be administered over 27 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI
recmage-a3 + as15 asci
5 doses will be administered (intramuscular) 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
(Placebo Comparator)
placebo
5 doses will be administered (intramuscular) 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 Outcomes

Measure
Disease free survival
time frame: 5 years

Secondary Outcomes

Measure
Overall survival
time frame: 5 years
Disease-free survival (DFS)
time frame: 5 years
Disease-free specific survival (DFSS)
time frame: 5 years
Distant metastasis-free survival (DMFS)
time frame: 5 years
(Serious) Adverse events
time frame: 5 Years
Immune response to recMAGE-A3 + AS15 ASCI
time frame: 5 years
Translational research on gene signature and expression
time frame: 5 years
Translational research on gene signature and expression
time frame: 5 Years
Translational research on gene signature and expression
time frame: 5 Years
Translational Research on tumor microenvironment and lymphocyte infiltration
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Aged greater than or equal to 18 years at the time ICF is signed, either sex. 2. Histologically confirmed (after cystectomy or if needed transurethral resection) urothelial carcinoma of the bladder which is MAGE-A3 positive. 3. Written informed consent for tissue sampling, the mandatory analyses and for the complete study has been obtained prior to the performance of any other protocol-specific procedure. 4. TNM classification at pathological examination of surgically removed specimen: Stage T2,3 N0 or N1 or N2 and M0 disease or Stage T4 N0 M0 disease. 5. The patient is free of residual disease and free of metastasis, as confirmed by a negative baseline Computer Tomogram (CT scan) or Magnetic Resonance Imaging (MRI) of the pelvis, abdomen and chest no more than 13 weeks prior to randomization. Other examinations should be performed as clinically indicated. 6. Patient is fully recovered from surgery within 13 weeks following cystectomy. For patients who receive adjuvant chemotherapy, the patient is fully recovered within 3-6 weeks following chemotherapy. 7. The patient must have adequate bone-marrow reserve, defined as an absolute neutrophil count 1.0 x 109/L, and a platelet count ≥ 75 x 109/L, adequate renal function, defined as a serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN), and adequate hepatic function, defined as a Total bilirubin ≤ 1.5 times the ULN, and a Alanine transaminase (ALAT) and Aspartate Transaminase (ASAT) ≤ 2.5 times the ULN as assessed by standard laboratory criteria. 8. World Health Organization (WHO) performance status 0 - 1 at the time of randomization. 9. If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series. 10. The patient should be affiliated to health insurance or benefit of such an insurance Exclusion Criteria: 1. The patient has previous or concomitant malignancies at other sites except effectively treated non-melanoma skin cancer, cervical carcinoma in situ, incidental localised prostatic carcinoma or effectively treated malignancy that has been in remission for over 5 years. 2. The patient has received any anti cancer systemic treatment, including immunotherapy (local intravesical BCG is allowed), chemotherapy, except: - For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancer, cervical carcinoma in situ, incidental localised prostatic carcinoma or effectively treated malignancy that has been in remission for over 5 years). - For the treatment with neo-adjuvant chemotherapy for their muscle invasive bladder cancer - For the treatment with adjuvant cisplatinum-based chemotherapy for their muscle invasive bladder cancer 3. The patient has received radiotherapy of the abdominal or pelvic region, within 6 months prior to randomization. 4. Women who are pregnant or breast feeding. 5. The patient has a known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C. 6. The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product. 7. The patient has any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases as. Patients with vitiligo are not excluded to participate in the trial. 8. Patient has received a major organ allograft. 9. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. Note: the use of prednisone, or equivalent, < 0,125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted. 10. The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study. 11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. 12. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. For example, but not limited to: uncontrolled congestive heart failure or uncontrolled hypertension, unstable heart disease (coronary heart disease or myocardial infarction), uncontrolled arrhythmia or patients taking anticoagulant treatment or having a coagulation disorder. 13. The patient uses alternative treatments eg. plant extracts. 14. Adults under legal supervision

Additional Information

Official 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
Principal investigator Peter FA Mulders, Prof,PhD,MD
Description This study will assess an investigational treatment for patients with Muscle Invasive Bladder Cancer in whom the urinary bladder has been surgically removed. The investigational treatment aims to increase the body's immune response to a specific antigen expressed by the cancer. The tumour tissue will first be tested whether it expresses the MAGE-A3 antigen. The MAGNOLIA study is open to male and female patients with pathologically confirmed muscle invasive transitional cell carcinoma of the urinary bladder with expression of the antigen MAGE-A3 with or without limited lymph node involvement who have no evidence of disease after surgery confirmed with imaging procedures (scans CT/MRI).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by European Association of Urology Research Foundation.