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

NCT01435356 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2019-01-09

Study results available
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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.

Conditions

  • Urinary Bladder Neoplasms

Interventions

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • European Association of Urology Research Foundation

    lead OTHER

Principal Investigators

  • Peter FA Mulders, Prof,PhD,MD · EAU Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-04-07
Completion
2017-04-07

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435356 on ClinicalTrials.gov