NCT01435356

Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: European Association of Urology Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial was 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 was administered over 27 months.

Detailed description

This study assessed an investigational treatment for patients with Muscle Invasive Bladder Cancer in whom the urinary bladder had been surgically removed. The investigational treatment aimed to increase the body's immune response to a specific antigen expressed by the cancer. The tumour tissue was first tested whether it expressed the MAGE-A3 antigen. The MAGNOLIA study was 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 had no evidence of disease after surgery confirmed with imaging procedures (scans CT/MRI).

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	recMAGE-A3 + AS15 ASCI	5 doses were 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
BIOLOGICAL	Placebo	5 doses were 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

Timeline

• Start date: 2011-08-01
• Primary completion: 2017-04-07
• Completion: 2017-04-07
• First posted: 2011-09-16
• Last updated: 2019-01-09
• Results posted: 2019-01-09

Locations

50 sites across 10 countries: Czechia, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine