NCT01284205

First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bioniche Life Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Mycobacterial Cell-Wall DNA Complex	8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
BIOLOGICAL	Bacillus Calmette-Guerin	mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-02-01
• Completion: 2017-02-01
• First posted: 2011-01-26
• Last updated: 2014-08-29

Locations

14 sites across 1 country: United States