Study Stopped
This indication is not being pursued at this point in time.
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
1 other identifier
interventional
N/A
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2010
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 29, 2014
August 1, 2014
4.1 years
January 25, 2011
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (8)
Disease-free survival rate at 2 years
Month 24
Frequency, severity, and nature of drug-related AEs
Baseline through 24 Months
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
Frequency, severity, and nature of drug-related SAEs
Baseline through 24 months
Number of treatment delays and their reason
Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
- +3 more secondary outcomes
Study Arms (2)
MCC
EXPERIMENTALIntravesical Administration of Mycobacterial Cell-Wall DNA Complex
BCG
ACTIVE COMPARATORIntravesical Administration of Bacillus Calmette-Guerin
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Englewood, Colorado, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Garden City, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Myrtle Beach, South Carolina, United States
Unknown Facility
McAllen, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 26, 2011
Study Start
January 1, 2010
Primary Completion
February 1, 2014
Study Completion
February 1, 2017
Last Updated
August 29, 2014
Record last verified: 2014-08