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

Primary Purpose

Bladder Cancer

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mycobacterial Cell-Wall DNA Complex
Bacillus Calmette-Guerin
Sponsored by
Bioniche Life Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring non-muscle invasive bladder cancer, superficial bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCC

BCG

Arm Description

Intravesical Administration of Mycobacterial Cell-Wall DNA Complex

Intravesical Administration of Bacillus Calmette-Guerin

Outcomes

Primary Outcome Measures

Duration of disease-free survival (time to recurrence, progression or death) in all patients
Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs

Secondary Outcome Measures

Disease-free survival rate at 2 years
Frequency, severity, and nature of drug-related AEs
Duration of progression-free survival (time to progression or death) in all patients
Frequency, severity, and nature of drug-related SAEs
Number of treatment delays and their reason
Frequency, severity and nature of all AEs
Number of treatment discontinuations and their reason
Duration of Survival (time to death from any cause) in all patients

Full Information

First Posted
January 25, 2011
Last Updated
August 28, 2014
Sponsor
Bioniche Life Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01284205
Brief Title
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
This indication is not being pursued at this point in time.
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bioniche Life Sciences Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
non-muscle invasive bladder cancer, superficial bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCC
Arm Type
Experimental
Arm Description
Intravesical Administration of Mycobacterial Cell-Wall DNA Complex
Arm Title
BCG
Arm Type
Active Comparator
Arm Description
Intravesical Administration of Bacillus Calmette-Guerin
Intervention Type
Biological
Intervention Name(s)
Mycobacterial Cell-Wall DNA Complex
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Bacillus Calmette-Guerin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of disease-free survival (time to recurrence, progression or death) in all patients
Time Frame
Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Title
Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
Time Frame
Baseline through 24 months
Secondary Outcome Measure Information:
Title
Disease-free survival rate at 2 years
Time Frame
Month 24
Title
Frequency, severity, and nature of drug-related AEs
Time Frame
Baseline through 24 Months
Title
Duration of progression-free survival (time to progression or death) in all patients
Time Frame
Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
Title
Frequency, severity, and nature of drug-related SAEs
Time Frame
Baseline through 24 months
Title
Number of treatment delays and their reason
Time Frame
Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Title
Frequency, severity and nature of all AEs
Time Frame
Baseline through 24 months
Title
Number of treatment discontinuations and their reason
Time Frame
Baseline through 24 months
Title
Duration of Survival (time to death from any cause) in all patients
Time Frame
Baseline through month 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
City
Laguna Hills
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Englewood
State/Province
Colorado
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Garden City
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Myrtle Beach
State/Province
South Carolina
Country
United States
City
McAllen
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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