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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01284205
• Other study ID #: EN3348-302
• Status: Withdrawn
• Phase: Phase 3
• First received: January 25, 2011
• Last updated: August 28, 2014
• Start date: January 2010
• Est. completion date: February 2017

Study information

• Verified date: August 2014
• Source: Bioniche Life Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationCanada: Ministry of HealthAustralia: Therapeutic Goods AdministrationNew Zealand: Ministry of HealthIndia: Ministry of Health and Family WelfareRussia: Ministry of HealthUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)

• histologically confirmed diagnosis within 42 days of study treatment

• life expectancy of greater than 5 years

• ECOG performance status of 2 or less

• absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment

Exclusion Criteria:

• current or previous history of muscle invasive bladder tumors (>T2)

• current or previous history of lymph node and/or distant metastases from bladder cancer

• current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder

• current systemic cancer therapy

• previous immunotherapy for bladder cancer

• previous intravesical chemotherapy treatment

• contraindication to use BCG of known tolerance to BCG

• history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)

• patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bioniche Life Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of disease-free survival (time to recurrence, progression or death) in all patients		Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24	No
Primary	Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs		Baseline through 24 months	Yes
Secondary	Disease-free survival rate at 2 years		Month 24	No
Secondary	Frequency, severity, and nature of drug-related AEs		Baseline through 24 Months	Yes
Secondary	Duration of progression-free survival (time to progression or death) in all patients		Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60	No
Secondary	Frequency, severity, and nature of drug-related SAEs		Baseline through 24 months	Yes
Secondary	Number of treatment delays and their reason		Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24	Yes
Secondary	Frequency, severity and nature of all AEs		Baseline through 24 months	Yes
Secondary	Number of treatment discontinuations and their reason		Baseline through 24 months	Yes
Secondary	Duration of Survival (time to death from any cause) in all patients		Baseline through month 60	No